Six Concepts to Navigate Manufacturer-Sponsored Clinical Trials
What you need to learn before thinking about seeking Medicare reimbursement for a clinical trial.
Production and operations managers—make sure your preventative maintenance procedures are up to snuff.
Differing approaches to risk could hamper further growth of combination products.
This year’s work plan includes several items that will impact medical device manufacturer and suppliers.
FDA Transparency at Heart of Device Risk and Recall Discussion
The last decade has brought more interaction between the device industry and FDA related to conducting health hazard evaluations, but companies continue to face obstacles.
Changes to ISO 13485: What to Expect
A summary of the new and revised changes in ISO 13485, the second Draft International Standard (DIS2), which is planned for release this fall.
Build the Right Medical Device Recall Team
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
Device Manufacturers Still Grapple with Recall Risks and Next Steps
Industry needs to understand that they do not classify a recall, the agency classifies it, advises former FDA official Steven Niedelman.
Medical Devices in Canada: How to Enter the Market
When launching a new product, manufacturers may want to consider Canada first.
EU Notified Body Unannounced Audits and Your Suppliers
The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.