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Rebecca Beausang
Regulatory Affairs Specialist, Scilife
Rebecca has over seven years of experience in medical device and other regulated industries. Alongside her expertise in FDA submissions, EU MDR compliance, and ISO 13485 QMS implementation, Rebecca is skilled in creating clear and impactful regulatory content. From technical documentation to compliance blogs, she excels in translating complex topics into engaging, actionable insights. Her passion lies in using compliance as a strategic tool to drive innovation and trust in regulated markets.
Medical device quality assurance can feel overwhelming, especially when you’re balancing product development, regulatory updates, and real-world patient safety. But the truth is, getting QA right is one of the most reliable ways to keep your product ...
If you work in the medical device industry, you already know that medical device risk management is a part of the job from the very beginning. Whether you're bringing a new product to market or continuing with an existing one, the way you approach ri...
As of February 2, 2026, the transition period for the Quality Management System Regulation (QMSR) has officially ended. The FDA now expects full compliance with this new framework, guaranteeing that FDA 21 CFR part 820 and ISO 13485 operate as one.
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