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Home » Global Regulatory

Global Regulatory

Global medical device regulatory strategy statistics infographic showing $623 billion global device market in 2026, FDA QMSR effective February 2, 2026 replacing QSR with ISO 13485:2016 by reference, EUDAMED mandatory for EU market access from May 28, 2026, 12 to 18 month notified body backlogs threatening December 2027 Class III MDR deadlines, and over 1,000 FDA-cleared AI medical devices with 295 authorizations in 2025 alone.
July 9, 2026
by VelSafe Editorial Team Insights

Global Regulatory Strategy for Medical Device Manufacturers: 40+ Statistics on QMSR, EU MDR, EUDAMED, and AI Devices Through 2026

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Who Is Legally Accountable in a Change Control Failure Quality, Operations, or Management
July 20, 2025
by VelSafe Editorial Team Law

Who Is Legally Accountable in a Change Control Failure? Quality, Operations, or Management?

In pharmaceutical and biotech manufacturing, changes to processes, equipment, or materials must be handled carefully. That’s why change control is a critical part of any company’s current Good Manufacturing Practice (cGMP) system. But when change con

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CE Marking Timeline Tips From Classification to Certification
July 20, 2025
by VelSafe Editorial Team Tips

CE Marking Timeline Tips: From Classification to Certification

If you’re a manufacturer looking to sell your product in the European market, CE marking is a legal must. It’s more than just a label. It shows that your product meets the European Union’s health, safety, and environmental standards.But getting that

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