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April 2023

New update from MDSAP Audit Approach – MDSAP-AU-P0002.008

Regulatory Updates /

New update from MDSAP Audit Approach, at a glance: a) Australia got some more detailed requirements regarding Assessment Technical Documentation and Agreements between Sponsors and Manufacturers b) Update of Design Output requirements for Technical Documentation and DHF c) Auditors shall search for evidence of inclusion of feedback into risk management, both Product and Processes d) […]

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Swissmedic has performed inspections at class 1 manufacturers

Knowledge & Resources /

Swissmedic has performed inspections at class 1 manufacturers within Switzerland. The result is impressive, but not surprising due to our experience als Authorised Representative in EU, Switzerland and UK. During our onboarding process EUMEDIQ, we check not only completeness of Technical Documentation of our customer, we also do a plausibility check in order to estimate

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