Posts by Alexandra Reid

Alexandra Reid

Medical Device Coverage & Reimbursement Tips and Trends

Expert Advice from the 16th Annual Medical Device Coverage & Reimbursement Conference A medical device sponsor must feel like they have successfully climbed Mount Everest when they receive their approval from the FDA – but in reality, they’ve only reached the first Base Camp. There is still a challenging uphill climb before receiving the real […]

Alexandra Reid

FDA Guidance on Non-Clinical Bench Performance Testing Information

Your Roadmap for Premarket Submissions Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.

Alexandra Reid

Bringing Consistency to the FDA’s Inspection Process

Leveling the Playing Field with recent Draft Guidance Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms. The FDA’s plan is outlined in a short, six-page document released March 29, […]

Alexandra Reid

Double your biotech R&D budget

5 tips to a successful academic-industrial partnership Costs are rising for research so how do you maximize your biotech R&D budget? Form an academic-industrial partnership. Perhaps you are working on a disruptive technology and need an expert to assess that your assay is better than the accepted standard? Or maybe you’ve had a pet research […]

Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.