Phone: +49 511 62628630
Fax: +49 511 62628633
Area of business Services and Publications
Medical Device Safety Service GmbH (MDSS)
We forge powerful alliances and provide excellent solutions for our clients’ protection, benefit and corporate endurance. MDSS opens the door to Europe with the best representation in the ever-changing maze of European Regulations.
MDSS, your first class address on your product, shall be synonymous to quality products and compliance with European Medical Device requirements.
MDSS serves clients’ specific needs with changes of products and regulations. Each client is unique and different. MDSS customizes the solution for each one.
As the European Authorized Representative, MDSS is responsible for your product in Europe according to the:
• Medical Device Directive (MOD) 93/42/EEC
• Active lmplantable Medical Device Directive (AIMDD) 90/385/EEC
• In Vitro Diagnostic Medical Device Directive (IVD) 98/79/EC
Our service is an extension of your quality system, fulfilling your regulatory obligations in Europe