Create Your Own Gift Card

Create Your Own Gift Card

If you need to send someone a special halo, but you have a budget or can only send a gift in the form of an envelope, then making a card with your own two sneaky hands is the way to go. Making cards easy and affordable. Even if you live outside of cereal you can use a cereal box as a backrest for your card and an old pasta to create an art inspired noodle.
If you still feel uninspired, we’ve created a list of ideas (with pictures,) that we offer you from our experience, it will help keep your creative stream flowing. So grab some scissors and glue, wear stylish aprons and let’s fall cunning!

Create Your Own Gift Card

TAPE LONG MIX

After you buy your CD player there is no space in your life for music tapes anymore. The little fingers that music plays magically are now another piece of impractical plastic in your bedroom garbage pile. Today you will free them from the dumpster and refresh them again into art.

Draw a picture of your receiver’s base on the front of your card. Take off your ribbon and cut a haircut that reflects your current recipient’s key. Now re-create your friend’s hair with a piece of ribbon attached to your card. You are now drafting a craft.

BITS, BOBS & BUTTONS

Make a visit to the local charity shop and find jewelry, buttons, and old beads to create your masterpiece. Try and find colors like colors so you can make your drawing into a coherent shape.

Draw an outline of your image on your card. You may want to do faces or even just a balloon for a birthday greeting card. Fill your objects with the colors you choose and then create a background with different colors. If you use the gift recipient’s face as an inspiration, use different beads and color buttons to create colors and light. If you can draw this one, you can get the crafting genius badge.

KOLASE

Take an old magazine, a pair of scissors and some glue. From here the options are endless – endless in the use of these three items. You can cut the pretty picture you like and make landscape or just cut the color and create your own miracle. Magazines allow you to cut a bit of text too, so maybe you can add something smart about the effects of gravity when you’re forty years old in the body. Everyone loves good jokes about their age.

SEWING

Why not make a card with a needle and thread? With a single color of wool or yarn you can create a heart-like shape for Valentine’s or Christmas tree shapes. Outline the shape you want to do on your card with a pencil. Then stir the hole through the outline of the card with your needle and remove the pencil. Now, attach the color you use to your needle and sew the color through the hole you have made until you fill the shape. Easy!

SPARKLING

We all love sparkling things. If it makes us happy. That means glitter is a perfect addition to a birthday card where you want to add a sweet comment like ‘You make me sparkle’. Make a shape on your card and paint your glue inside the shape line. Add glitter (free). Remove the excess and present it with a flourish. Create Your Own Gift Card

Primary Itch Member Midsection Lice

Primary Itch Member Midsection Lice

Whether walking on the streets or hot dates with a couple he wants to impress, an itchy member is an inconvenience to anyone. The urgent need for scratching can be embarrassing and makes men seem in dire need of a bit of cold. What’s worse is when there are genuine male organ health problems associated with itchy members – such as bedbugs. When this small attacker is present, someone wants to make sure to get rid of it as soon as possible.
About fleas

Primary Itch Member Midsection Lice

Midsection ticks are parasites that tend to accumulate in the middle of the body. They are related but not the same as head lice or body lice. (And they are not the same as thousands of other species that, fortunately, affect animals and not humans.) As the name suggests, head lice are mainly found in the head, usually on the scalp. They rarely travel to other parts of the body. Body lice, on the other hand, are usually found in clothing and not on the body itself. When clothing is in contact with the body, it can cause itching, etc. And if the clothes are in the middle of the body, body lice can make members itchy.

But most of the time, when ticks cause itchy members, it’s because of bedbugs.

Midsection lice

Midsection of everyday language lice is known as crabs. That is because, if using a magnifying glass or a microscope to see them (only 1-2 mm in length), the color resembles a crab. They love hairy places and tend to stick to the middle hair or in the skin close or stick to such hair.

Unfortunately, bedbugs are very common, with about 3,000,000 cases each year in the United States. On the plus side, though uncomfortable and undesirable, the baby’s bedbugs are harmless.

There are three phases in colon lice:

1) Egg (or nit), oval, yellowish or white, and attached to the hair of the middle part of the body. Nits hatch about 6-10 days.

2) nymph. The early stages of this tick grow in 2-3 weeks. The diet is blood, obtained from the host.

3) Adults. Usually brown or grayish white, adults also eat blood. Without a host, adult lice die within a few days.

As mentioned, the colon lice do not spread the disease, but they itch like crazy. Often a man can scratch so much that he damages his skin, which in turn can cause an infection.

Scattered through contacts

Midwifery lice spread through contact, most often sensual. When a person has sensual activity with a person with lice, some lice or eggs may be transferred to the partner of the skin rubbing the skin. However, sometimes someone compresses bedbugs from other sources, such as sheets, towels, or clothing.

Treatment

Men with itchy members because bedbugs should consult a doctor to get treatment recommendations. Shampoo and special medicines are usually recommended to kill fleas in the body. Nits can be resistant to treatment and may need to be removed manually. In addition, it is usually necessary to take steps to remove any ticks that may have fallen. Fully wash the sheets, clothes, and towels needed; Items that are not machine washable may need to be cleaned dry.

Midsection ticks not only cause itchy members but can result in skin damage due to scratching. The top organ male health messenger application (health professionals recommend Man1 Man Oil, which is clinically proven to be mild and safe for the skin) can help restore damaged skin. The best creme will contain a combination of moisturizers, such as high-end emollients (such as Shea butter) and natural hydrators (such as vitamin E). Together, they can rejuvenate damaged skin. To keep free radical damage from susceptible skin, choose a crème that also contains powerful antioxidants, such as alpha lipoic acid.

Primary Itch Member Midsection Lice

Designer company Solis Betancourt

Designer company Solis Betancourt & Sherrill renovated the pre-war home to create a colorful pied-à-terre that can highlight the client’s Latin American art collection.

Washington-based designers Paul Sherrill and Jose Solis Betancourt have really turned into this colorful, colorful, colorful Latin American apartment. It is important to create an interior that reflects the elegant lifestyle and eclectic collection of client’s art, but it can also be a comfortable place where clients can spend time with their grandchildren. This is the fourth residence Solist Betancourt & Sherrill designed for clients, they decided that pre-war apartments have great bones, but require dramatic updates. The native of Puerto Rico, his client is accustomed to the bright colors of the Caribbean and wants to combine that spirit in his new apartment. The dining room paintings by Puerto Rican artist Rafael Ferrer are important to families, so designers use bright colors as inspiration for the home.

Designer company Solis Betancourt

Playing in originality and experimentation of style files, and highlighting color interactions, we see walls painted in intense blue; then covered with gold plated wall coverings, and a texture-like mesh pattern that allows visible wall color. Bright colors and contemporary art – by Puerto Rican artist Olga Albizu; the sculptured canvas of the 1970s by Cuban-born artist Zilia Sanchez and on the sofa is Linling Lu’s circular work; and paintings by Puerto Rican artist Wilfredo Chiesa … filling the interior with a narrative that seeps into the atmosphere. The living room melds vibrant colors and contemporary art while maintaining the elegance of a traditional salon. Striped chair seats, benches beneath the console table; an ottoman coffee table, and a brilliant Gournay silk damask for the dining room wall with a contrasting silk curtain resuming a bright color scheme while he provides privacy. Four club chairs (in casters for easy maneuvering) surround a minimal ‘ghost’ table that brings modern elements into the room. The private area does not have a quiet color palette. Sleek panel hide storage. Little ornaments that stand apart, however, blend comfortably with decorative canvas, ornaments on cushions, cushions, table blankets and free-flowing curtains, intentional deliberate deliberate performances (flowers on vases, fruit on a table next to a fruit bowl) , and its kind. There is a touch of excessive fabric – texture, pattern, and style of curtains. Designer company Solis Betancourt

Medical tourism is a move from one own country

Medical tourism is a move from one own country to a foreign country to get medical help. The transport sector has seen many people traveling to different destinations with the aim of seeking better medicine than those offered in their home countries. Most of these types of travelers are found to be from developing countries, where there is no better medical service.
India has become the preferred choice for most medical tourists. It has been found to have affordable medical services and competent healthcare professionals in that field. With years of development, India has developed its infrastructure, modernized its facilities and health services and has brought more medical practitioners into the job market. With all these resources and financial support, the country has seen itself competing with other giants in the medical arena. The diversity of work in Indian medicine gives them a voice in the world forum.

Medical tourism is a move from one own country

India has leveraged modern developments and incorporated internet and science technologies to produce this excellent recipe of success. Speculation is even higher about the efficiency of medical services and the inclusion of medical tourists to the country in the coming years. With an estimated 30% annual growth of its health sector, you can not miss the mark on where the state health sector is – Excellence.

No one wants to be treated by unqualified health practitioners who have never had a history in the field. Health is a worthy asset handled with care and most people will spend thousands of dollars just to be treated by a qualified professional even if it means crossing the border. A large number of people, mostly from developing countries, as stated earlier, seek the services of Indian medical professionals through Indian medical tourism for various reasons: India offers affordable services compared to other countries abroad. This service is largely not built on trial and error, but has a basic knowledge and experience. In this country you are sure to find medical practitioners who are majoring in any field. They use advanced equipment to provide health services and ensure patients about safety in medical operations.

No country can pass a major development concession without financial aid. India has realized this and formulated every strategy that will make them maintain their space in the competitive health arena. With the cooperation between the ministry of tourism and the health ministry, the country has increased revenues from medical tourists and normal tourists. With scenic tours and beautiful infrastructure, India is promoting a health tourism sector that sees holiday people and medical duties entering the country.

It should be noted that not a professional can perform his duties effectively without relevant equipment and equipment, not forgetting a good working environment. India understands all of this and that’s why it has mobilized all its resources to ensure that its medical field is supported to fully operate with the help of a state-of-the-art healthcare agency.

Medical tourism is a move from one own country

Maintaining Member Health by Choosing the Right Barrier Protection

Maintaining Member Health by Choosing the Right Barrier Protection

When a man enjoys all the pleasures the new partner has to offer, he must continue to maintain excellent member health – and to do so, he has to choose the right protection. Using the right barrier protector is one of the most important principles of psychiatric care. But choosing the right protection is not as simple as walking to the store and buying the first package that looks good. This is what people need to know to wrap it up properly.
The barrier protection option

Maintaining Member Health by Choosing the Right Barrier Protection

Choosing the right barrier protection brings men with dizzying choices, from the light that shines in the dark to the weirdest. Here’s what to know about each option.

1) Size. Each manufacturer offers a variety of sizes, and the size may be slightly different from the next manufacturer. In the end, that means there are dozens of barrier protection sizes to choose from. A man should experiment with different brands, and then size within each brand, until he finds the perfect fit.

2) Tip of the reservoir. When a man is wearing a protective barrier, the seed must go somewhere. If there is no reservoir tip, the wind will probably penetrate the thin sap, thereby damaging the protection effort. While it may be tempting to try some fitting models, for the best protection, a tip reservoir is the only way to go.

3) Color. If the size can make a man’s head spin, just wait for the color! Every possibility is on the table. Although the color is not very important in terms of adequate protection, a man who wants to make his equipment look a little bigger should always choose a protective device with lighter colors, or bright colors, such as neon or pink yellow.

4) Flavors. This may be important for people who like oral action and want to make sure their partner enjoys it as well. The available flavors are almost endless. Keep in mind, however, that new barrier protection should still have a reservoir tip – they should provide protection and also pleasure.

5) Eco-friendly choice. Now there is a protective barrier that is environmentally friendly or made of organic material. Before going to this route, a man must ensure that barrier protection is as strong as the latex option in preventing disease transmission. Assuming them, hey – why not show Mother Nature a little love when she gets it?

6) Ribbed, encrusted and more. Usually marketed as “for fun,” this fun device has ridges, ribs, buttons, ripples and more that gives a little extra sensation. There’s even a shield with an embedded vibrating ring that’s meant to give a little extra ‘toughness’ when he needs it.

7) The strange and unusual. From a spray barrier protection (currently in testing phase) to a sleeve device and a latex combo device to which only covers the tip of maturity but not its axis, there are many strange choices out there. A man should always ensure that the protection he chooses is thoroughly tested and approved as a protective device against infection, as well as a disease that will inevitably continue throughout strenuous activities.

8) Seeds of blockers or lubes? Some barrier protection comes packaged with block or lubrication blockers already in it. The only caveat for this is ensuring that a man (or his partner) is not allergic to the ingredients. After trying this protection, make sure no one is involved with rashes or other irritations where barrier protection touches their skin. Maintaining Member Health by Choosing the Right Barrier Protection

Finally, always make sure the maturity is ready to rumble with the regular application of top-class health personnel (health professionals recommend Man 1 Man Oil, which is clinically proven to be mild and safe for the skin). A good crème laden with Shea butter and vitamin E can help against dry skin that may occur after the use of barrier protector, thus keeping the skin supple, smooth and attractive. Maintaining Member Health by Choosing the Right Barrier Protection

How To Save Your Car Insurance

How To Save Your Car Insurance

It has car accounts as the second largest household cost, according to the Bureau of Labor & Statistics. Although their efficiency is still a matter of debate, we all know as car owners that it’s better to be safe than sorry. In this article we will discuss various ways to save hundreds of dollars on your Car Insurance.
1. Look Around to find The best prices may vary depending on the company and its policies. With the latest statistics released by BankRate.com, 90% of drivers pay more than $ 368 for their car insurance. So really pay to look around and expand your options. One of the nuisance methods is to search online. Many of them offer discounts compared to normal Insurance. So always weight your choices and find the best.

How To Save Your Car Insurance

2. Secure your car and get discounts on bells and bullets Insurance related Insurance in U.S. car. get a lot of discount points from car insurance companies. Built-in anti-theft and passive restraints include a large discount air bag. Insurers also love cars kept in the garage overnight, because there is a higher theft risk by keeping your car on the road.

3. Cancel Closure If your car is 10 years old or the price is less than 10 times the premium, the cost of repairs can be more than a decent car. Chances are you’d better cancel your crash coverage and save up to 40% or as much as $ 440 per year by reducing coverage of property injury and damage.

4. Think Twice before Adding Your Teenagers to Your Policy According to a report issued by InsuranceQuotes.com, car insurance costs 79% more for couples after they add a teenage driver to their policy. Especially if the teenager happens to be a boy: car insurance costs 92% more for teenage males, but only 67% more for young women. This is because car accidents are the leading cause of death for U.S. teens, especially males aged 16 to 19, according to the Centers for Disease Control. How To Save Your Car Insurance

5. Bundle all your Insurance into one company Insuring your home and your car with one company can bring your interest rate down by 10% per year. A two-year national study by Consumer Reports found that bundling of home and car insurance will save customers an average of $ 97 per year.

6. Choose High Deductibles if you have the cash The higher your deductible, the lower your insurance premium. If you can afford a higher out-of-the-pocket cost if something happens to your car, choose a $ 1,000 deductible instead of $ 500 to save. How To Save Your Car Insurance

7. Mind Your Credit Score According to a study conducted by the Wallet hub, there is a 49% difference in the cost of auto insurance premiums for someone with excellent credit and someone who has no credit history. Another study by Consumer Reports says the average difference between the causes of the difference in credit score is $ 214. So whenever your score improves, ask your insurance company to get a discount or shop for other policies.

Whatever You Get Whenever You Want to Be Known by Bookmarks

Whatever You Get Whenever You Want to Be Known by Bookmarks

Often, markers are generally a big expense. They can be expensive and they can certainly spark an interest that can make you more confident. But how do you find the weapon you like? Just read it and you’ll get it done except

Whatever You Get Whenever You Want to Be Known by Bookmarks

Pay attention to the boy’s readiness when getting a completely new firearm. Small weapons can pose a risk to babies and toddlers who naturally put everything in their lips. Make sure the fresh rifles are usually kept clean of small children. Firearms that have been reserved for toddlers can certainly frustrate the younger children.

Fantastic weapons must be protected and attractive. Regarding young adults, look for pistols that educate this individual’s safety and accuracy. You can find weapons that will be caught dependably once the proper trigger will be pressed. Young adults generally learn to enjoy both yourself as well. Mastering by participating in is the greatest training. Whatever You Get Whenever You Want to Be Known by Bookmarks

Create your own young teens to get guns by giving your favorite gadget guns they can do. Any firearm toy with a non-lethal bullet is usually well-liked. Your son or daughter can easily experiment with creating his intentions. Many gun gadgets have a focus on just putting young people can practice shooting smaller things.

Always check the label associated with the shotgun. Today, you do not find some pistols made with harmful elements like we did many years ago. Still, you can still find some on the market. Most of these markers can harm your children, do they really consume the element of the idea. Whatever You Get Whenever You Want to Be Known by Bookmarks

Bring your young children next to each time looking for their own weapons. Unless of course you are already aware of what they are asking for, which firearms bets they might like will be reachable and well cared for. This is likely to ensure that many people get a lot of things that will definitely get pleasure. Also, the idea convinces you that you do not lose your money on any weapon that will not be provided.

In the case of almost any weapon you buy for a young child working with an electric package, be sure to take them out a las vegas bankruptcy adolescent attorney will accompany him. Choosing stunned how easy it is for each child to see the battery of some kind of marker with a bite or maybe chew it. Not giving them a chance to do this.

Uncover weapons that may have many insurance policies. There is a kind of constant rifle that might involve a teenager. By studying the actual store exchange policies, it can help you save a lot of trouble.

10 Reasons to Buy an Independent Life Insurance

10 Reasons to Buy an Independent Life Insurance

Your employer may provide life insurance coverage as part of a group plan, and you may be fine with it. However, there are several reasons why your group insurance is not sufficient. Here are 10 main reasons why you should talk to insurance companies about West Palm Beach life insurance purchases independently.

You never know what will happen

10 Reasons to Buy an Independent Life Insurance

Unfortunately, you never know what will happen to you. Anything can happen anytime. If the worst happens, and you are not ready for it, then your loved ones will be left paying all your fees and bills.

Replace your Earnings

If you work at the time of your death, your family will probably need that income to live. A complete insurance policy will help your family recover once you have died by giving them the income you will carry over your life.

Your Funeral is Not Free

Funerals can cost up to $ 10,000 and sometimes even more. Money from your life insurance policy can go to pay this fee, or your family can pay for it. When it comes to that, you may want your family not to worry about funeral expenses.

Protect Your loved ones

Throughout your life you have worked to protect your family. You still want your family to be taken care of after you die. This is what life insurance will do for you. If they have to get on with their lives without you, then they should be able to do it the same way they used to.

You Can not Take It With You

The hard truth is that you can not carry your things with you, but there’s something else left behind when you die: your debt. Regardless of how much you have, this is a debt you may not want to pass on to your loved ones.

Protect Your Business

If you think that life insurance is just for you as an individual, you will be wrong. Life insurance will also keep your business protected from financial losses and liabilities.

Keep Up Your Pension

One thing that many people do not know is that you can actually use your life insurance to extend your retirement savings. If you play your cards correctly, you can put your money into annuities that pay a steady income each month for the rest of your life.

Use Common Sense

Life insurance is just a smart financial move. This is considered a financial asset. Your assets increase your net worth and your ability to get loans and credits. In addition, creditors can not touch protected policy funds even in the event of bankruptcy.

Be Charitable

One of the other benefits of having an independent life insurance policy involves your ability to get your insurance money to go further. A life insurance policy allows you to reward a charity after you die that is far greater than you can give to your own money.

Have a Pure Peace

The biggest reason to invest in a life insurance policy is for your own peace of mind. Although the funds from your life insurance policy will never be enough to replace you, life insurance can protect your family from undue financial difficulties after you leave.

Many people do not realize the importance of West Palm Beach life insurance policy. Having an independent insurance agent helping you find the right life insurance product for you can ensure your family and loved ones are protected after you die. 10 Reasons to Buy an Independent Life Insurance

Antioxidants for Healthy Men’s Organ Skin

Antioxidants for Healthy Men’s Organ Skin

Because many men consider their maturity primarily in terms of their usefulness in sensual activity, they do not always remember that the health of good members means more than just taking steps to ensure hard work. But in fact, there are many aspects of the health of different members, including taking steps to ensure healthy male organ skin, both for practical and aesthetic reasons. Part of maintaining the health of male organs involves the incorporation of antioxidants into the routine of male care.
What is an antioxidant?

Antioxidants for Healthy Men’s Organ Skin

At the technical level, antioxidants are molecules that help prevent other molecules from oxidizing. Oxidation, in turn, is a chemical process that creates something called free radicals, which can then cause damage to cells, such as skin cells. They can also contribute to heart disease, cancer and other health conditions. However, not all free radicals are bad, and some are beneficial. For example, oxidation is important in helping the liver detoxify food and body to help fight certain bacteria.

At a rate that is more than molecular, antioxidants refer to vitamins, minerals and nutrients that have the ability to retain these free radicals (and the damage they do).

How do antioxidants help the skin?

Many skin care products are rich in antioxidants, as keeping oxidative stress from damage to skin cells helps ensure skin health. There are many things that can damage the skin, both on the surface and on a more molecular level. The stronger the skin at the molecular level, the better it is able to withstand attacks on the surface. Antioxidants for Healthy Men’s Organ Skin

How does one get antioxidants?

The body itself makes some antioxidants and relies on a healthy diet to help complete this amount. Some foods are rich sources of antioxidants than others. According to the U.S. Department of Agriculture, the following is a very high diet containing antioxidants:

– Goji berries

– wild blueberries

– Dark chocolate

– Pecans

– Artichoke

– Elderberries

– Red beans

– Cranberry

– Blackberry

– Coriander

And these are some of the ingredients that are an excellent source of antioxidants:

– Cloves

– Cinnamon

– Oregano

– Turmeric

– Chocolate seeds

– Cumin

– dried parsley

– Basil

– Ginger

– Timi

As mentioned earlier, many skin care products are also a good source of antioxidants. This can be very important because skin damaged by free radicals can be vulnerable – and unattractive as well.

Free radical damage is one of the things that cause the skin to appear earlier in old age. This can cause drying and cracking, wrinkles and stains that can damage the skin of interest.

It’s just like the skin of a male organ because the skin elsewhere is in the body. The skin of a male organ is naturally very smooth, so maturity is more readily accepting friction and stimulation. It can also make it more susceptible to cracks and wrinkles. When cracks appear on the skin of members, they can also open up pathways for bacteria to enter, creating further member health problems.

For this reason, the male organ skin needs to be exposed to healthy levels of antioxidants. One way to help achieve this is through the day-to-day application of first-degree healthcare professionals (health professionals recommend Man1 Man Oil, which is clinically proven to be mild and safe for the skin). Clearly, to be effective, the creme must include antioxidants. This can be more easily achieved if crème contains vitamin A and C, and alpha lipoic acid. All three have antioxidant abilities. Vitamin A has the added bonus of fighting off bacteria that cause odor, while vitamin C also helps give skin to a man’s skin with the required tone and elasticity. Alpha lipoic acid has powerful antioxidant properties and also helps increase vitamin C. Antioxidants for Healthy Men’s Organ Skin

Complaint Handling Adverse Event Reporting

Complaint Handling Adverse Event Reporting

Medical device makers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, ISO 13485: 2016, recognizes this fact. Different requirements of each regulatory system require manufacturers to identify their roles, as well as regulatory requirements for the role, and then incorporate them into their Quality Management System. Various jurisdictions, however, address the problem of post-market devices in various ways. Complaint management, reporting of adverse events and withdrawals are three interrelated and interrelated processes that need to enter SMM. Corrective action and design changes, which support the QMS process; also Complaint Handling Adverse Event Reporting need to complete these three processes. And then, regulatory requirements, which typically involve areas such as recording and reporting, are also entered. Course on how to implement an integrated QMS GlobalCompliancePanel, a leading professional training provider for all regulatory compliance areas, organizes excellently educational and valuable learning sessions about these primary and secondary SMM processes and how they need to be understood and implemented in conjunction with US, EU, and Canada. Dan O’Leary, president of Ombu Enterprises, LLC, a company that offers training and implementation in Operational Excellence, which focuses on analytical skills and systems approach to operations management, will be the director of this two-day seminar. And brings more than 30 years of experience in the field of quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical laboratories. Want to benefit from Dan’s rich experience and want to understand how to implement integrated SMM where various aspects of complaints, reporting and adverse withdrawal are built? Please sign up for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900960SEMINAR?Article-SEO. The seminar was approved by RAPS eligible for 12 credits against RAC recertification after completion. Alignment with FDA FDA The degree of alignment with the requirements of the FDA Quality Management System (QMS) is an interesting one from the final version of the ISO 13485: 2016 standard, which is now available. The alignment rate set at 2016 versions in 13485 may be much higher than the previous version of 2003; However, there are still some points where it deviates from the FDA QMS. Companies that must comply with these standards should keep this in mind. Now after ISO 13485: 2016, the Medical Single Audit System (MDSAP), and the new EU Medical Device Regulations have been introduced; companies need to update their QMS and integrate all elements if their implementation is to be effective and appropriate. In this two-day session, Dan will provide the tools the participants need for this. The agenda of this learning session is as follows: • Regulatory Structure? FDA QSR? ISO 13485: 2016 and regional variants? ISO 14971: 2007 and regional variants? Implementing MDSAP? EU Medical Device Regulations • Maintenance? Identification of problems ? Serving data analysis? Feedback to the grievance process • Complaint Identify complaints? Evaluate a complaint? Investigating a complaint? Complaint data analysis? Put it into a corrective action process? Feedback to risk management process • Corrective Action? Develop the process? Analyze product and process information? Determine the next action? Put it into the design process? Feedback to risk management process • Design and Design Change? Determining the need for design changes? Documenting the design changes? Design change verification and validation? Feedback to the risk management process? Input into the pre-market delivery process • Risk Management? ISO 14971: 2007 and regional variants? Entering post market information • Updating Pre-Market Submissions? US – Guide 510 (k)? EU – Technical files and design documents? Canada – License change • Bad Event Reporting? US – MDR? EU Alert Reports? Canada – Mandatory Obligatory Reporting • Remember? US – Corrections and Removals? EU – Corrective Action of Field Safety? Canada – Remember Complaint Handling Adverse Event Reporting