How are in vitro diagnostic (IVD) devices similar and different from medical devices? How should IVD manufacturers approach quality management and other key elements based on these similarities and differences?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Joanne LeBrun from MDC Associates, which offers quality systems consulting, regulatory consulting, and implementation training.

Joanne offers valuable insights on the topic of managing quality for in vitro diagnostic devices and the unique relationship these devices have to medical devices in terms of industry best practices and tools that manufacturers can use to produce high quality devices that are safe and effective for end users.

• IVDs are different from medical devices and therefore treated differently. The difference between IVDs and medical devices is the way performance is proven.
• Read the FDA and EU regulations for medical devices and IVDs because changes are immense for the classification of devices. 
• The amount of growth for IVD startups is driven by the up cropping of contract manufacturers. There’s a lot more bringing it to market with less resources.
• The pandemic has been good for the medical device industry and for bringing products from concept to fruition and through regulatory approvals quickly.
• Don’t reinvent the wheel. Focus on your technology and seek advice from quality professionals to achieve efficiency and effectiveness.
• Or, make space for the FDA to move in for months for an inspection and audit. Do the right thing and know what the right thing is. Keep your audit manageable.
• Perform quarterly quality fire drills with a robust internal quality audit program to prepare ahead of time. Review inventory, complaints, deviations, and more to be current on compliance. 
• Big Mistakes and Common Challenges: Starting design control and risk management too late. It doesn’t take that much effort to document work. 

“The difference between IVDs and medical devices is the way that you can prove performance.”

“The quality systems are similar, but if you’re a medical device person and you’re headed into an IVD situation, do keep in mind that it is quite different and the rules for IVDs are just a little bit more forgiving than in a medical device arena.”

“There’s a lot more bringing it to market with less resources to be able to use some of those contractors.”

“The pandemic, while it’s been very hard on a lot of people and I don’t certainly belittle that, it has been very, very good for our industry and has been very good for bringing products from concept to fruition and through regulatory approvals so fast, maybe too fast.” 

Joanne LeBrun on LinkedIn

MDC Associates

FDA - Medical Devices

European Union Medical Device Regulation (EU MDR)

EU IVDR

ISO 13485 Quality Management for Medical Devices

Abbott Laboratories

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru