European Medical Manufacturing Suppliers Directory Index

Medical Device Safety Service (MDSS) GmbH

Burckhardtstrasse 1
Hannover, D-30163 Germany
Tel: +49 5116 262 8630
Fax: +49 5116 262 8633

Web: http://www.mdss.com
E-mail: info@mdss.com

MDSS – The Access to the European Market for your Medical Device

MDSS was founded in 1995 as one of the first Authorized Representatives on the market. As a German company operating on the biggest healthcare market in Europe, we stand for proficiency and liability – the most important aspects for a business being specialized in regulatory affairs. We provide our customers with unique professional expertise on "CE Marking" Regulatory Affairs for medical devices. We act on our clients’ behalf, as required by the directives with the European Commission, National Competent Authorities, and distributors, in all types of regulatory affairs, including member state regulations.

Manufacturers should be careful to designate an Authorized Representative who is qualified to represent the manufacturer's interests in the EEA in regards to the EU Directives. It was for precisely this reason, that MDSS was created. Because of our long-standing experience within the medical device manufacturing industry, we recognized that manufacturers would have the greatest difficulties in finding a suitable ‘Authorized Representative’ - one that would match the criteria and over and above that, have sufficient qualifications in Regulatory Affairs to be able to provide this demanding and highly ‘responsible’ type of service!

Our Philosophy

MDSS, your first class address on your product, is synonymous to quality products and compliance with European Medical Device requirements. Each client is unique and different. MDSS customizes the solution for each one. We forge powerful alliances and provide excellent solutions for our clients’ protection, benefit and corporate endurance. MDSS stands for continuity and safety throughout the European Community with experience and stability. MDSS opens the door to Europe with the best representation in the ever-changing maze of European Regulations.

Why to appoint MDSS as your AR

We provide full service, around-the-clock, 365 days a year. To compensate for time differences and to generally improve communication, we offer extended office hours.

MDSS’ unique and professional expertise on Regulatory Affairs of CE Marking for your medical devices includes:

• Representation of our clients to the European Commission and National Competent Authorities
• Product Vigilance with Incident Reporting and Advisory Notices
• Registration of your products with the EU Authorities
• Verification on product classification
• Assistance with Conformity Assessment Procedures
• Assistance with Quality Assurance Systems
  (EN ISO 9001, EN ISO 13488, ...)
• Safety Office for Germany and other applicable states
• Advise on Technical Documentation with Essential Requirements, Risk Analysis and Labeling
• Declaration of Conformity
• Updates on European Regulatory Affairs and identifying compliance strategies

In addition to the comprehensive service that we offer, our customers take advantage of our very competitive price structure which is based on a set price. You may evaluate for yourself the costs. With an hourly rate there is no incentive for the Authorized Representative to do the job fast! MDSS with its set price guarantees a fast execution of your registration as well as a professional and qualified consultation at any time.

Our Staff

The team behind MDSS has a comprehensive knowledge based on significant Regulatory and Industry experience. Our team includes Physicians, Engineers, and Laboratory Technologists, dedicated and highly motivated to provide the best customer service for our clients. Our regulatory affairs personnel provides expert knowledge on technical and legal matters associated with the registration of products in the countries in which our customers wish to distribute their products. We provide considerable experience of all aspects of European Regulation (CE marking) and an extensive understanding of both medical device development and product safety testing.

The president of MDSS worked at TUV in the US for several years, and therefore, he has inside knowledge of regulatory approval process and knows well the difficulties, a manufacturer can be confronted with (e. g. regarding certification or required corrective action by the Notified Bodies).

In addition to our staff, MDSS has professionals on call for special expertise as f. e. language skills, medical expertise and evaluation of incidents: Another expert of our team holds both a medical and an engineering degree. In case of an incident, he is not only able to evaluate the product, but also the influence on the patient. Our safety officer, mandatory only in Germany, guarantees the necessary expertise for evaluating incidents.

MDSS is multi-lingual. All members of our staff are fluent in English. In addition, some of our personnel speak French and Italian and Spanish as well. This turned out to be very helpful, especially when dealing with the authorities.

Categories this company is listed under in the European Medical Manufacturing Suppliers Directory:

• Consultants: Auditing/Inspections (67 companies)
• Consultants: Conformity assessment (43 companies)
• Consultants: Equipment safety (19 companies)
• Consultants: Product certification (43 companies)
• Consultants: Registration/Submission assistance (53 companies)
• Consultants: Regulatory (105 companies)
• Consultants: Risk management (50 companies)
• Consultants: Technical documentation (72 companies)
• Testing: Test houses: Product testing (92 companies)