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MDSAP – Medical Device Single Audit Program
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ISO 13485 Auditing Service
SOP – IOP
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Clean Room Design and Validation
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MDR 2017/745
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CH-REP – SAR Swiss Authorized Representative service
EU PRRC
Technical File Design Dossier
Clinical Evaluation
DHF Design History File
Risk Management Process
ISO 14971:2012 – 2019 Gap Analysis
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ISO 10993-17 Toxicological Evaluation
Cardiovascular Digital Simulation Model
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