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Latest From Medtech Tips
Guest author Paul Kostek of software engineering services firm Base2 Solutions offers device-makers pointers on how to mitigate certain risks and make sure that safety is always a top concern when products are designed.
In this edition of Medtech Tips, Ilya Kazi, a partner at intellectual property firm Mathys & Squire LLP, provides top tips on what medtech businesses should do in order to help protect their IP and avoid risks to their inventions.
Medtech Tips: First-Rate Problem Statement Key To Failure Investigations, Cardinal Health Quality VP Says
A clear, succinct problem statement is the backbone of a winning device failure investigation, Karl Vahey says. He notes that a well-developed statement is also useful to have on hand when regulators conduct a facility audit and review corrective and preventive action (CAPA) activities.
Medtech Tips: Should A Combo Product-Maker's Quality System Be Device- Or Drug-Led? J&J, Eli Lilly Experts Weigh In
How manufacturers of drug-device combination products set up their quality system depends on various factors, including the primary mode of action – the constituent part of the product that offers the most overall benefit. So say experts from Johnson & Johnson, Eli Lilly and PAREXEL, who offer other tips and advice.
FDAer-turned-consultant Heather Rosecrans offers valuable tips for a successful submission, from avoiding sending a PMA or 510(k) to the agency during the annual holiday season, to requesting a copy of an FDA reviewer's work through a Freedom of Information Act request – and more.
Medtech Tips: 'Don't Be A Data Dump' When Submitting New Products For US FDA Review, Pre-Market Expert Says
Heather Rosecrans, former head of the FDA device center's 510(k) review staff, says manufacturers should be careful not to bombard the agency with a mountain of unnecessary information in new product submissions. She also offers advice on what firms should do if they run into problems with a reviewer.
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