It's a constant debate. Pursue a medical device regulatory approval in the US? Or does it make more sense to seek a European approval first? Is there a definitive answer? According to Marc Sanchez, Founder of Contract In-House Counsel, medical device companies would be wise to take a step back and consider the business ramifications first. In this interview with Marc, we learn more about this hotly debated issue as well as a host of other interesting medical device regulatory trends.
Regulatory and Compliance
Notified bodies are pushing for adoption of the third edition of IEC 60601-1. But this expensive and burdensome standard has its critics, including some regulatory bodies, says Grant Ramaley.
On Friday, the IRS released proposed regulations on the implementation of the medical device tax. AdvaMed and Erik Paulsen (R-MN) quickly released statements stressing the need for swift action to repeal the tax, which is scheduled to go into effect in January 2013. Today, Todd Rokita (R-IN) and 74 co-signers sent a letter protesting the device tax to Speaker John Boehner, Majority Leader Eric Cantor, Majority Whip Kevin McCarthy, and Ways and Means Chairman Dave Camp.
Mark Kramer answers 5 questions on comination products and the regulatory hurdles manufacturers can face.
Dutch lawyer and blogger Erik Vollebregt analyses guidance on stand-alone medical software published by the European Commission.
A colleague and I visited with a startup company last week, one that was designing a product that can detect certain ailments through your breath. Named Menssana Research, the company is housed across the street from the New Jersey Institute of Technology, in a building owned by the college (which just happens to be my alma mater).
It’s all in the Timing. If you are a business leader at a company that sells active or powered medical devices, the looming question for the past several years has been “When do I certify my medical devices to IEC 60601-1:2005 also known as the third edition?” This is a complicated question, with many variables to consider before choosing a path appropriate for your business including the following:
In merchandising, customer satisfaction plays a significant role in measuring a product’s postmarket performance. It is also an indicator of how effective the product performance is managed. Both the quality system regulation (QSR) and the International Organization for Standardization (ISO) require procedures and processes to monitor and control customer complaints. The complaint-handling mechanism not only collects feedback from unsatisfied customers, but also provides means for failure investigations and subsequent corrective and preventive actions (CAPA).
Return to Article: Converting CAPA to an Advantage
Return to Article: Converting CAPA to an Advantage Top Five Device Observations Used in Turbo EIR* (FY 2007)
REGULATORY OUTLOOK: ONLINE EXPANDED VERSION
True and robust Corrective and Preventive Action (CAPA) systems are more than just a formal mechanism for tracking problems, says an FDA expert on quality systems. They must encompass a number of data sources, including complaint handling, nonperforming product mechanisms, Medical Device Reporting, corrections, removals, and recalls, said Jan Welch, a quality systems expert in CDRH's Office of Compliance. She spoke as part of an audioconference on implementing an effective CAPA system , held March 6.
Originally Published MDDI May 2006 Q & A Industry continues to be deficient in complaint-handling procedures despite FDA having made those a priority for a long time. A new survey aims to help change that.