MDSS Consulting: Your Partner for Medical Device Registration
Medical Device Directives (MDD, IVDD, AIMDD) and FDA registrations (510(k), PMA)
MDSS was founded to provide high quality service as a competent partner for regulatory affairs. Our customers are manufacturers, importers, exporters and distributors of medical devices and in vitro diagnostics.
The registration of medical devices confronts the manufacturers with significant challenges. National and international regulatory requirements are continually developed and specified. Alongside the well-known registration and certification procedures in the United States (FDA) and Europe (CE), every month new regulations for many other countries appear. The perfect way to the market is not always easy to define and requires a wide range of experience.
MDSS offers high quality consultancy service to pave the way to the target market for your company and the products you manufacture.
The range of the MDSS service varies from quality management, clinical investigations and risk evaluation to a complete conformity assessment (for details see Consultancy section).
The CE mark enables free movement of goods within the European Union. However, the national implementations of the directives for medical devices and in vitro diagnostics partially require a country-specific registration. MDSS has been registering medical devices in Italy, Spain, Portugal and France for years and can support you with its vast experience.
While the CE mark enables the penetration of the European market, non-EU countries which did not sign the Hague Convention require a so-called Free Sales Certificate (Certificate of Marketability). MDSS arranges for the issuance of Free Sales Certificates with the competent authorities and takes care of necessary attestation and apostilles.
We kindly invite you to visit all areas of the MDSS website to find out how MDSS can assist your company.
Please note: Due to constantly changing regulations, the MDSS website may not always be up to date.
If you become aware of such inconsistencies, we would appreciate a short feedback.
Concerning this matter, we would also like to draw your attention to our Links category where you can always find the most recent information. (Please click here and you will be immediately directed to our Links page).
MDSS is a member of the European Association of Authorized Representatives and certified in accordance to ISO 13485