Guides, tips, and professional knowledge on ISO 13485, medical device regulation, and quality systems implementation.
FDA clearance and a CE mark are necessary but not sufficient for AMAR registration. Importers who arrive with the opposite assumption lose one to two years — sometimes more.
Israeli companies arriving at AS9100 certification with an existing ISO 9001 typically assume they are 80% of the way there. In practice they are closer to 60% — with the missing 40% concentrated exactly in the areas that cause audit failures.
The Notified Body market in 2025–2027 is tighter than ever — limited capacity, long lead times, and an overloaded NB can delay your product launch by a full year. Here is how to choose correctly.
I have filed over 40 510(k)s in twenty-five years. The most common RTA trigger? Not a technical deficiency — but the gap between what FDA expects to see in eSTAR and what the team thinks it wrote.
Most teams blur the distinction between hazard and hazardous situation — and their NB finds it. This guide breaks down the Risk Management File structure under ISO 14971:2019 including the 2024 Amendment, and shows exactly where NBs flag gaps.
Around 70% of legacy CE marks issued under MDD face re-certification under MDR. If you're an Israeli MedTech company with an old CE mark, this isn't a regulatory update — it's an operational emergency.
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