"MDSS Consultancy - your international partner for medical device registration"
Medical Device Directives (MDD, IVDD, AIMDD) and FDA registrations (510(k), PMA
For more than 15 years MDSS has been a competent address for regulatory affairs concerning medical devices and in vitro diagnostics. Our clients are manufacturers, importers and distributors of various kinds of medical devices.
The regulatory framework binding the manufacturers of medical devices is complex and subject to constant changes. Keeping track of everything is fairly difficult. We assist you with this task, so you can focus entirely on your business.
We support you competently with the registration of medical devices and offer a comprehensive service, making it easier to cope with the complex regulatory tasks connected with the process of manufacturing, placing on the market and distributing your medical devices.
Together we can handle every situation and keep up with the changes!
MDSS has an optimally trained and experienced staff. Also, we are a known and respected partner for the Competent Authorities.
Our service covers all areas of the development, manufacturing and market placement of medical devices.
We support you with the construction and maintenance of quality management systems according to the DIN EN ISO 13485 norm (also involving the MDD, IVDD, AIMDD, 21 CFR 820, CMDR or other national requirements).
Our service includes also the setup and maintenance of technical documentation, so you are continually up to date. Of course we are always well-informed regarding the recent changes in requirements. You will not miss any regulatory change to be taken into account for your product.
If necessary, we provide staff members to act as interim management staff at your company. Furthermore, we offer taking over safety officer duties as stated in §30 of the MPG (German Medical Device Act) for manufacturers of medical devices.
It goes without saying that all of these solutions are tailored to your particular company.
Feel free to contact our consultancy team.
Main areas of consultancy:
- CE Marking
- Quality Management
- Risk Management
- Conformity Assessment
- Technical Files
- Clinical Evaluation
- Safety Officer
- Interim Mangement
- Research of Norms
- Supplier Audits
Ihr MDSS Team