White Paper Archives - Medical Device Navigator

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White Paper

Intertek — Usability Engineering for Medical Devices: IEC 62366

Eurofins — Extractables and Leachables Testing for Medical Devices

BSI — Post-Market Surveillance and Vigilance Under EU MDR

SGS — EU MDR Readiness Guide: Technical Documentation and Common Non-Conformities

SGS — Biocompatibility and Chemical Characterization for Medical Devices

DNV — EU MDR Compliance: Person Responsible for Regulatory Compliance (PRRC)

Dekra — Quality Management System for Medical Devices: ISO 13485:2016

TÜV SÜD — EU MDR Compliance: UDI, EUDAMED, and Economic Operator Obligations

TÜV SÜD — Biocompatibility Testing for Medical Devices: ISO 10993 Guide

TÜV SÜD — Cybersecurity for Connected Medical Devices: IEC 81001-5-1

TÜV SÜD — IVDR Transition Guide: From IVDD to EU 2017/746

TÜV Rheinland — Risk Management for Medical Devices: ISO 14971:2019

BSI — MDR Transition Guide for Medical Device Manufacturers

BSI — Clinical Evaluation Under EU MDR: Requirements and Best Practices

BSI — Software as a Medical Device (SaMD) Classification and Certification

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