Results for
Germany
Our experienced team has for years done documentation for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements. For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services: Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR Creating QM-Systems with procedural instructions and work instructions Technical Documentation Clinical evaluation Risk Management / Risk Analysis Essential Safety and Performance Requirements Validation of processes UDI-labeling Consulting for Regulatory Affairs Internal audits and external supplier audits Accompaniment and support with inspections by authorities and Audits by notified bodies Communication with authorities
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Results for
External audit - Import exportNumber of results
1 ProductCompany type