Posts by Alexandra Reid

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Leveling the Playing Field with recent Draft Guidance   Review and Update of Device Establishment Inspection Processes and Standards, a draft guidance document from the FDA, establishes uniform processes and standards for FDA’s Inspection Process of both domestic and foreign medical device firms.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 […]

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 […]

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