GWK-Munich.com
GWK-Munich.com
Description: MDC Engineers and Manager Regulatory Affairs provide medical-technical and regulatory knowledge. We consult, design and manufacture medical devices, in-vitro-diagnostic and laboratory equipment, which reflect the state-of-the-art and fulfill market-specific regulatory requirements.
consulting (24477) notification (146) design and development (61) guideline (40) competent authority (5) essential principles (4) assessment / evaluation (3) specific function (3) instruction for use (3) technical documentation (sted-file)
MDC Engineers and Manager Regulatory Affairs provide medical-technical and regulatory knowledge, especially for health software and in-vitro-diagnostic. We consult, design and manufacture medical devices and laboratory equipment, which reflect the state-of-the-art and fulfill market-specific regulatory requirements.
Registration of Medical Devices Registration Processes in EU and USA Representation in EU Market Vigilance
Conformity-Check of Medical Devices 93/42/EWG and In-Vitro-Diagnostics 98/79/EWG Classification STED (Standard Technical Documentation), 21 CFR 820.30 Design Control Risk Analysis EN ISO 14971 Electromagnetic Compatibility and Electrical Safety EN ISO 60601 for Medical Devices and EN 61010 for In-Vitro-Diagnostics Software EN ISO 62304 and 82304 Biocompatility EN ISO 10993 Usability EN ISO 62366 Implementation of Quality Management System EN ISO 13485
GWK-Munich.com
GWK-Munich.com