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Quality Systems for Medical Device Manufacturers

Whether your organization designs, develops, and or manufactures what are considered medical devices, in-vitro diagnostics, or biotechnology classified as non-metabolic, such as collagen based products, throughout most of the civilized world today, you need a quality system, and for economic survival, it needs to be certified or registered by an accredited third party organisation known in Europe as a Notified Body and internationally as a registrar. 

If you distribute medical devices in Canada, registration from a CMDCAS recognised registrar to the ISO 13485:2003 standard is required.  If you distribute medical devices in Europe, ISO 13485:2003 registration is required.  If you are already certified , but your quality system costs are through the roof, check out our Quality System tune up.

21 CFR 820, also known as the Quality System Regulation (the QSR) replaced the FDA's Good Manufacturing Practices (the cGMPs), applies to companies in the USA and abroad, selling and distributing in the USA.  Over the past few years, FDA has stepped up its inspection program for manufacturers resulting in more FDA-483 Inspection Observations, especially for manufacturers who in past inspections received NAI (no action indicated) or VAI (voluntary action indicated) EIRs (Establishment Inspection Reports).  FDA-483's in Management Responsibility and Corrective and Preventive Action are the most frequent, and often the most serious, resulting in warning letters if not responded to in a timely and comprehensive manner.  CRO Group offers a FDA Mock Inspection service, where an experienced consultant will take your company through the average 56 hour QSR inspection in between 12 and 36 hours, and address each of the four main inspection modules.  Under MDUFMA (Medical Device User Fee and Modernization Act of 2002) the FDA implemented a special program in which accredited third parties may conduct QSR inspections.  However, to date, the program has not experienced significant use.  For more information on CRO Group's Mock Inspection services click here.  For more information on how we may be of assistance if you're considering the Third Party Inspection program, click here.

ISO 9000 is a series of international standards for quality systems, the most well known being ISO 9001.  Today, there is not an industry that does not have at least one ISO 9000 certified company.  First in Europe, then throughout the world, governments decided that medical device manufacturers which conformed to ISO 9001 would be a benefit to public health and safety.  ISO 9001 was substantially revised in 2000.  Companies registered to ISO 9001:1994 will lose their registration status effective December 15, 2003 unless they pass an ISO 9001:2000 registration audit prior to that time.   Check out our ISO 9001 2000 page for more information.

EN 46001 was the first European Quality Systems standard for medical device manufacturers.  If your company was certified to this standard for CE marking, your CE marking status is no longer valid.  Companies in this situation need to upgrade to the EN ISO 13485/8:1996 certification.

ISO13485 is an International Standard for quality systems for medical device manufacturers recognized in all first and many second world countries including the USA, Canada, the EU, Japan, and Australia. Most medical device manufacturers must be registered to the first release of this standard, in 1996, by a recognized Notified Body/Registrar as a pre-requisite for product approvals.  A revision to the standard was released in 2003, and certification to the revised standard is required by July, 2006 in order to retain CE Marking or Canadian licensing of products.

CMDCAS is the Canadian Medical Device Conformity Assessment Scheme for quality systems for medical device manufacturers. Most medical device manufacturers must be registered to the Canadian 1998 version of the ISO 13485/8 standard, by a CMDCAS recognized Registrar as a pre-requisite for product licensing..

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