Quality is a concept that is often overcomplicated in the medical device industry. With complexity comes mistakes, which is why it's so important for manufacturers to simplify!

In this episode of the Global Medical Device Podcast Jon Speer is joined by Mark Alpert, director of quality at Greenlight Guru with thirty years of industry experience in quality, about the past, present, and future global landscape of medical device quality.

• Mark and Jon agree that the medical device industry is at a crossroads currently because Europe is a ‘hot mess’ when it comes to quality. Countries with different agendas and requirements led to inconsistencies and interpretations of laws.
• It takes time, often several years, for companies to transition to new or revised regulations and standards. 
• Some companies are only beginning to implement, adopt, and change their processes in a way that they understand what risk-based approach means for their management systems.
• Some medical device companies have lost their way when it comes to quality, and many believe the quality profession is partly to blame for being driven by tools, not data.
• Mark describes a do versus don’t do mindset to bring creativity, objectivity, and ability to scale back into the procedure process, such as during audits.
• Do not seek or expect perfection. Do the best you can to move forward and know that there are opportunities for improvements. Demonstrate confidence, compliance, and processes in place that drive improvement.

“I think today, we’re also at a very interesting crossroads when it comes to quality. There’s a number of different facets.” Jon Speer

“It’s going to take years before companies can really adopt, implement, flow down, and make it inherent in how they do business every day.” Mark Alpert

“Once complexity creeps into the system, you’re just about guaranteeing mistakes will be made that will result in some non-conformances.” Mark Alpert

“A lot of companies, I think their quest is towards compliance.” Jon Speer

ISO 13485

ISO 9001

FDA - Medical Devices

FDA - Quality System Regulation

European Union Medical Device Regulation (EU MDR)

European Union In Vitro Diagnostics Regulation (EU IVDR)

Mark Alpert on LinkedIn

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Greenlight Guru YouTube Channel

Greenlight Guru