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What You Need To Know About FDA Remote Medical Device Inspections Back in 2021, I wrote that FDA should have the authority to inspect medical device facilities remotely. This would allow FDA to check these facilities when in‑person inspections weren’t possible. The remote inspection argument was especially compelling in the throes of Covid-19, which …
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New Resource Sheds Light on FDA CDRH Regulatory Focus Device developers seeking insight into the current thinking of the FDA Center for Devices and Radiological Health as well as those pursuing a career in regulatory affairs have a new resource available. Elijah Wreh, Professor of Regulatory Science and Senior Manager Regulatory Affairs at Boston …
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Developing an Effective and Sustainable Regulatory Strategy for Today’s Global Market Global regulatory demands for medical devices are increasing substantially, and regulatory teams are faced with the pressure of increased workloads and the need for more resources. To help regulatory professionals identify strategies and best practices in developing an effective and sustainable regulatory strategy …
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Protecting Innovation in FemTech As opportunities for innovation and investment in women’s healthcare accelerate, Femtech is helping to match capital and talent to unmet needs[1], enabling better outcomes for female patients and consumers, stakeholders, and society at large.[2] Broadly defined, Femtech provides a wide range of solutions to improve healthcare for women across a …
MedTech Developers Can Improve Surgical Workflows Through Thoughtful Innovation A surgeon’s workflow inside of the operating room, combined with their workload, has been studied widely but still stands to be better understood. A surgical workflow is an established pattern of processes that a surgeon repeatedly performs that minimize the potential occurrence for mistakes and …
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How Real-World Evidence Helps Medical Device Manufacturers Drive Value Real-world evidence (RWE) captured during the testing phase for medical devices and during the post-approval period helps key stakeholders understand the clinical outcomes that can be achieved by using a particular device—including by population. RWE also offers important opportunities to ensure medical devices are used …
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Best Practices and Pitfalls When Going from Concept to Commercialization MedTech Internet of things (IoT) start-ups and early-stage innovators often launch with a minimum viable product, or MVP, a version with just enough features and stability to be used in clinical or field-testing. With the right MVP, companies can prove technical feasibility and position …
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Connecting More Patients to Clinical Trials Improving diversity in clinical trials is a top priority in the life sciences industry, and rightly so. One-to-one representation of the population intending to use an investigational therapeutic is not just morally right, but also fundamental to its effectiveness. One of the biggest barriers to trials for underrepresented …
Laying the Groundwork for an AI Breakthrough Big data and artificial intelligence (AI) have been billed as “the next big thing” for more than a decade. Theoretically, these approaches present R&D groups in the medical device industry with enormous prospects. Realistically, many organizations have trouble realizing their full potential. Some businesses have resisted or …
Contamination Control: Practical Steps to Compliance with EU GMP Annex 1 In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect …
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