This newsletter from a medical device CRO covers EU and US regulatory developments for device makers, including EU Regulation 2026/977 on notified body oversight, EUDAMED, new GMP, the EU AI Act, and FDA leadership changes. Readers get a condensed view of which compliance steps and review timelines are most likely to affect their certification and product projects.
Website: https://clinsota.com/
A weekly healthcare cybersecurity briefing covering exploited vulnerabilities, vendor patches, breaches and incident recovery, regulation, and medical device alerts. Each issue states its reporting window and evidence cutoff and links to primary sources, with action points for security and clinical engineering teams.
BioCompounding publishes long-form equity research on medtech and biopharma companies, including earnings reviews and company deep dives. It also explains industry structure, such as how generics and biosimilars differ as businesses.
Hardware FYI is a weekly briefing for engineers, founders and investors building physical products. Its recent issues offer practical guidance on medical device prototyping, reverse-engineering parts without drawings, and R&D software that keeps design and documentation in sync.
Verolyx Cross-Sector Disruption Intelligence is a risk-monitoring newsletter that tracks supply-chain shocks, triggers and hidden interdependencies behind medical and health-security shortages, such as hurricanes hitting petrochemical feedstock, Ebola-driven PPE demand and chip allocation squeezes affecting medical devices. Each edition is a structured briefing with trend indicators, a classification of the risk type, and a watch list of what to monitor next.
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