WORLDWIDE MARKET APPROVAL FOR NEW MEDICAL DEVICES
Möller Medical is the right partner for european and worldwide market approvals for medical devices. Based on many decades of experience, a highly qualified team of experts is working in close business relationship with customers, authorities and distribution partners.
Möller Medical can function flexibly to meet your requirements. We can operate as a manufacturer in regulatory sense on the one hand as well as supporting our customers in the process of gaining their own medical approval on the other hand.CERTIFIED QUALITY MANAGEMENT SYSTEM
We deliver finished medical devices as well as components to our distributors and OEM customers. Customer satisfaction and compliance with all applicable legal, normative and regulatory requirements are the focus of our quality management system. To meet this requirement, Möller Medical has established a comprehensive quality management system. We hold the following certificates:
- QM system according to MDSAP (including the country-specific requirements of USA, Brazil, Canada and Austral
- QM system according to ISO 13485
- QM system according to ISO 9001
- Quality assurance system according to EC Directive 93/42 / EEC
The CE marking on the product gives notice to market surveillance authorities and end users that the product meets the essential requirements of applicable EU directives. The CE marking is also visible evidence by which a manufacturer guarantees liability for the conformity of the product. The CE conformity assessment procedure is carried out according to:
- Annex II of EC Directive 93/42 / EEC
- Annex V of the EC Directive 93/42 / EEC
The MDR (Medical Device Regulation (EU) 2017/745) is a great challenge for all manufacturers and suppliers in the medical device industry. We are happy to meet this challenge and have already planned our MDR certification audit for early 2021. Therefore we are confident that we will be able to prove MDR conformity at the latest by the time the MDR comes into force.
PRODUCTION IN CONTROLLED ENVIRONMENT
We have a wide range of manufacturing technologies and can therefore map much of the value chain in our business. The ambient conditions are always consistently tailored to the requirements of medical technology.
- Clean room production according to ISO 14644, ISO class 8
Intensive development work is constantly creating innovations that are protected by around 30 patents and utility models.