Most medical device manufacturers, both small and large, are not ready for the day when FDA or a Notified Body comes knocking on their door without warning. This and other potentially alarming details were released today from Greenlight Guru in the “State of Medical Device Product Development & Quality Management Report 2020”.

The firm surveyed more than 500 medical device professionals primarily in the functions of quality, regulatory, engineering and operations from small and large medtech companies.

Key findings of the report include the following:

• 75% are unprepared for an unannounced audit by FDA or Notified Body
  • Only 20% of these folks are prepared for an EU MDR audit
• Challenges to improving product development processes include:
  • Resource constraints: 55%
  • Lack of budget: 37%
  • No management support: 29%
• 71% says company-collected data about their quality management system does not have easy real-time accessibility
  o 60% of quality system-generated data isn’t consistently reliable

“Medical device manufacturers are taking huge gambles with their risk management; if management teams lack adequate insights into device risk, auditors lack sufficient insights, too,” said Jon Speer, VP of QA/RA at Greenlight Guru in a press release. “Revisions to ISO 14971 are coming soon, meaning issues with risk management now will create larger risk management issues in just a few months.”

A copy of the “State of Medical Device Product Development & Quality Management Report 2020” is available on Greenlight Guru’s website.