MDSS Consulting & Training
Consulting Services for the European Union
The health care policy in European countries has attracted greater public interest over the last years. The demand for a healthy life and increasing prevention as well as adequate medical care in the event of an accident or illness increase the demand for innovative medic al devices. Within the framework of these changes the requirements which are bestowed upon medical device manufacturers have become more specified.
The Medical Devices Directives (90/385/EEC, 93/42/EEC, 98/79/EC) and their implementation into national law (medical device law and decrees) have been revised several times and have been the basis for the marketing of medical devices in Europe. The scope of existing guidance documents for the implementation of guidelines (MEDDEV) and harmonized standards are permanently being concretized and extended. Medical device manufacturers have to fix their view firmly on new and / or changed requirements.
In the US, access to the market is determined by FDA requirements for medical devices. For decades the so-called Premarket Approval 'PMA' and Premarket Notification '510(k)' procedures have been the determining factors for registration in the U.S. The PMA path has always been obligatory for innovative products; the 'De Novo' procedure, introduced 1997 and little used for a long time, offers a possible shortened market access for such products as well.
The consultancy team of MDSS offers many years of experience in the interpretation and implementation of regulatory requirements. Through our consultation services we guarantee the secure handling of the following issues:
- CE Marking
- FDA Device Registration and Listing
- Quality Management
- Risk Management
- Conformity Assessment
- Technical Documentation
- Clinical Evaluation
- Safety Officer
- Interim Management
- Research of Norms
- Directive RoHS 2011/65/EU