Quality System for Entrepreneurs

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If you are here, it’s because you have probably heard about importance of a “Quality System” compliance for medical devices. Please do yourself a huge favor and read on. This may save you tons of time, money, and stress.

So, let’s start with – What is a Quality System and Why should you care?

Simply put, a “Quality System” ensures that medical devices are designed and manufactured to be – Safe and Effective. When you hear people talk about “Part 820”, “Quality System Regulation”, “QSR” or “GMP”, they are referring to the same thing.

Quality System requirements are quite expansive and cover – Management structure, trained personnel, internal audits, calibration, preventive maintenance, proper cleaning, validated manufacturing processes, qualified equipment, distribution controls and much more.

You can design and manufacture most user friendly, safe, effective, and reliable medical device in the world. Unless it designed and manufactured per Part 820, FDA considers it “adulterated” and therefore violative of US law. FDA can and does take serious actions against companies selling violative devices, including – inspection findings, warning letters, import embargoes, recalls, consent decrees, and criminal prosecutions.

Next, let’s discuss – When does Part 820 apply?

Part 820 applies for all classes of medical devices, except some that are “GMP Exempt”. Even though Part 820 compliance takes a lot of management commitment, time, and resources – it’s simply a cost of entry into the US Medical Device market. There are no shortcuts or waivers.

Finally, let’s discuss – How is Part 820 compliance achieved?

The simplest path to Part 820 compliance for an entrepreneur consists of two steps:

Design your device per Part 820 requirements, and then
Find an FDA registered contract manufacturer to manufacture, package, and label your device.

If you are importing devices from outside the US, a good alternative is to find an ISO 13485 certified contract manufacturer. With only a little effort, they can be made Part 820 compliant.

The worst approach is to select a contract manufacturer purely on basis on technical capability, cost, or physical proximity. Unless your first order is going to be worth hundreds of thousands of dollars – it is virtually impossible to persuade them to invest time and resources into getting Part 820 compliant just for you. Just don’t do it !

Vital Compliance has helped many clients achieve Part 820 compliance efficiently. Feel free to contact us if you have any questions.

Free Tool for DIY’ers – The attached checklist facilitates review of a contract developer and/or contract manufacturers against 21 CFR Part 820 and ISO 13485 requirements.

21 CFR Part 820 Tool

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