The Case For Quality: The Value Of The Voluntary Improvement Program

The Voluntary Improvement Program will increase the overall quality of the industry, members of the medical device quality community agreed during the MDIC Excellence and Quality Summit.

A panel on the Voluntary Improvement Program during the MDIC’s Excellence and Quality Summit from 23-24 July. • Source: Hannah Daniel

Medical device quality systems experts from across the total product lifecycle are enthusiastic about the US Food and Drug Administration’s Case for Quality Voluntary Improvement Program (CfQVIP), or VIP for short.

VIP, which grew from the FDA’s Case for Quality Pilot, was finalized in a guidance document in September 2023. It’s...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Regulation

Commission Decision Launches Pediatric And Rare Disease Expert Group

 

A revised annex to the original decision also outlines expert remuneration limits and introduces further changes.

Dermal Fillers For Décolletage May Gain FDA Approval

 
• By 

An upcoming US FDA advisory panel meeting will discuss adding a new indication to allow dermal fillers to be used in the upper chest, or décolletage. Plastic surgeons expect this could drive interest in the procedure, which is already performed off-label.

Planning To Take Part in MDUFA? FDA Wants To Hear From You

 

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

More from Policy & Regulation