Results for
CIC - KLAUS CZERWONKA
Germany
Taking on tasks in the field of design and development such as: CAD construction on CATIA and Pro E Component tuning installation space investigation Creation of 2-D drawings Documentation Change management
Request for a quoteMAXCERT LTD
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:āØ 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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Document management - Import exportNumber of results
2 ProductsCompany type