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Recent Posts
- So You Need to Field Evaluate Your Equipment – What You Need to Know
- Corrosion | Salt Fog Testing: Like taking your product to the beach
- Essential Performance: What It Is, Why It Matters, and When You Can Say “No Thanks”
- Adapting to Evolving U.S.-China Regulatory Dynamics
- REACH/RoHS and Continuing Compliance
Monthly Archives: August 2025
Corrosion | Salt Fog Testing: Like taking your product to the beach
Imagine this: your brand-new, bright, glistening product steps into a chamber. The door closes. Inside, it’s not the day at the spa it expected – instead – it’s a nightmare at the beach. That is Corrosion/Salt Fog Testing.. This testing … Continue reading
Posted in CE marking
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Essential Performance: What It Is, Why It Matters, and When You Can Say “No Thanks”
Let’s talk about Essential Performance—the term that sounds like it belongs in a motivational poster but is actually a cornerstone of medical device compliance. If you’ve ever stared at a test plan wondering, “Do I really need to define this?”—this … Continue reading
Posted in CE marking
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Adapting to Evolving U.S.-China Regulatory Dynamics
Medical device companies operating across U.S. and Chinese markets are facing a rapidly shifting regulatory environment. As geopolitical tensions between the two nations intensify, firms must reevaluate their global strategies—particularly when it comes to supply chains, partnerships, and compliance efforts. … Continue reading
Posted in CE marking
Tagged FDA, Medical
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