Mikrobiologia lekarska

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Applying ISO14971 and IEC62304 - A guide to practical...

Wydarzenie archiwalne Koszt: 1295.00 - 1495 USD Wyświetleń: 2833

Overview: This seminar covers the compliance issues relating to ISO 14971, IEC 62304 and IEC60601-1:2005. Especially the cross-standard and practical means to integrate...

How to Prepare and Submit a Bullet Proof 510(k) and...

Wydarzenie archiwalne Koszt: 1295.00 - 1495 USD Wyświetleń: 1904

Overview: This one-day course is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to...

Why is FDA at my Facility, and What do I do During an...

Wydarzenie archiwalne Koszt: 1295.00 - 1495 USD Wyświetleń: 1935

Overview: Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions....

The DHF, Technical File and Design Dossier - Similarities,...

Wydarzenie archiwalne Koszt: 1295.00 USD Wyświetleń: 3277

Overview: One of our most popular subjects, continuously updated with the latest U.S. FDA and European Union requirements. As U.S. companies go global, they must...

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