QM: meeting all requirements
In Germany, all medical devices are subject to the Act on Medical Devices. Together with its regulations it transposes the European directives 90/385/EEC (for active implants), 93/42/EEC (for other medical devices), and 98/79/EC (for in-vitro diagnostic devices) into German law. Manufacturers and/or distributors of medical devices are obliged to establish and maintain a quality management system (QMS) and have this system audited and certified through a notified body before placing the medical device on the market. Initial certification is followed by annual repeat or monitoring audits.
All medical devices are governed by the EN ISO 13485 standard ("Medical devices – Quality management systems – Requirements for regulatory purposes"). All requirements of this international standard relate specifically to medical engineering companies that manufacture and/or place on the market medical devices, regardless of the type or size of the company.
Metecon supports you with establishing and maintaining a QMS, with validation, as well as before and during audits and inspections through the authorities. You want to know more about QMS? We are happy to answer all your questions!
Our services in this field
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"First of all, quality management is a tool for controlling your company efficiently. If you lose time with QM, there is something wrong with it."