Category: Sparta Systems
There's nothing you can do about looming changes to the 510(k) program. But you can take the time to make sure your internal processes are up to snuff.
Arne Carlson, the former governor of Minnesota, recently contributed an opinion column to the Minneapolis Star-Tribune, voicing concerns about increased Food & Drug Administration regulation of the medical device industry stifling innovation. The column came as Dr. Jeffrey Shuren, director of the FDA's Center for Devices & Radiological Health, prepared to visit the state — one of the country's biggest medical device hubs — for a town hall meeting to discuss CDRH's 2010 Strategic Imperatives and hear feedback from industry officials.
Enterprise quality and compliance management software solutions can provide the consistency your company's audit system needs.
In the life sciences industry, many companies have a heightened sensitivity to risk due to increased regulatory scrutiny and/or product quality issues. As a result, the concern around compliance has renewed many organizations' focus on audit programs, which are being re-calibrated as a tool to identify the most vulnerable parts of the business.
Improving medical device safety from pre-review to post-market.
It pays to remember an old adage: "Better to be safe than sorry." Indeed, many medical device manufacturers are re-evaluating their quality systems as a result of the Food & Drug Administration's recent review of pre-market notifications and a FY 2011 budget request for additional funds to address product safety. Device makers should heed this advice and take the necessary steps to pro-actively — rather than reactively — address compliance issues.
