Call Us Today at 508-231-8842        EMERGENCY

Every responsible medical device manufacturer is aware that the FDA requires them to establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications – a protocol known as current good manufacturing practices (CGMP). These requirements were written into the original regulation issued back in 1978, which was revised, starting in 1990, into a broader and more consistent quality system (QS) regulation that is in effect today.

Of course, because the regulation must apply to so many different types of devices, the regulation does not prescribe in detail how a manufacturer must produce a specific device. Instead, the regulation provides the framework that all manufacturers must follow by requiring that manufacturers develop and follow procedures and fill in the details that are appropriate to a given device according to the current state-of-the-art manufacturing for that specific device.

The flexibility of the QS regulation and its applicability to finished devices can, in some cases, provide a level of uncertainty and as well as “wiggle room” for manufacturers when it comes to quality systems and assurance. Too much wiggle room in your quality process or too constriction in your procedures might lead to a non-compliant situation. Companies need a “Goldilocks” quality system for their company, addressing their specific needs. That’s why it’s so important for medical device manufacturers to work with an experienced medical device compliance consultant.

At MEDIcept, we provide clients with a comprehensive suite of quality assurance services to assist throughout the entire medical device design and manufacturing process – from design control to validation and production control to complaint-handling and corrective actions. We can help you build a quality assurance program from the ground up to meet FDA and ISO 13485 requirements. Our expertise is developing just the right sized quality systems without hand-cuffing you into requirements you do not need.

To help support the innovators who generate so many of our medical device industry breakthroughs, we’ve developed our unique Outsourced™ Quality Assurance (OSQA) program that provides a quick, compliant, and cost-effective QA solution to cash-strapped start-ups. This program jump starts your Quality Management System (QMS) with the required procedures and time-saving forms and checklists you need for easier QMS management and to help you achieve your product launch timelines. Our OSQA program provides crucial quality assurance support at a fraction of the cost of a full-time QA employee.

To learn more about our quality assurance services, including our OSQA program, FDA/ISO-compliant supplier qualification, risk management, and FDA audit assistance, give us a call today.

Sign up to receive our Newsletters!

The Latest News

Quality Systems in Motion, Inc. (QSIM) is now part of MEDIcept Inc.

For Immediate Release Ashland, MA: MEDIcept Inc, an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), and QSIM, a US-based privately held consulting firm specializing in medical device/biotechnology, announces the merger of the two companies. QSIM, under the direction of Brian Markham, President, specialized in providing leadership and resources for organizations undergoing significant quality system change due to...

Medical Device Risk Management: An ISO14971 Update

In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. This year, the ISO technical committee (ISO/TC 210) has been hard at work updating this globally-recognized standard. And while the fundamental stages of the risk management process remain unchanged, there are some key modifications that medical device manufacturers should be aware of to ensure that they can successfully navigate the development, testing, and launching of...

Europe’s New Medical Devices Regulation: Ready or Not, Here It Comes

For the past 30 years, the European Union’s medical device market has been regulated by the Medical Devices Directive (MDD). The rapid development of hybrid technologies, tensions between EU member states, and highly bureaucratic procedures for resolving disputes made the text of the Medical Devices Directives seem obsolete much earlier than anticipated. As a result, the European Commission authorized the development of a new set of industry requirements known as the Medical Devices Regulation...