Medical Device Safety Service GmbH (MDSS GmbH) of Hannover at MEDICA 2019 in Düsseldorf -- COMPAMED Trade Fair
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Medical Device Safety Service GmbH (MDSS GmbH)

Schiffgraben 41, 30175 Hannover
Germany
Telephone +49 511 62628630
Fax +49 511 62628633
info@mdss.com

Hall map

MEDICA 2019 hall map (Hall 10): stand B05

Fairground map

MEDICA 2019 fairground map: Hall 10

Our range of products

Product categories

  • 07  Medical Services and Publications
  • 07.10  Consulting services for health organisations

Consulting services for health organisations

Our products

Product category: Consulting services for health organisations

Consulting

The consultancy team of MDSS Consulting GmbH offers many years of experience in the interpretation and implementation of regulatory requirements worldwide.

Thanks to our consulting services, we guide your company safely though the jungle of laws, standards, directives and regulations.

MDSS Consulting GmbH combines a high-qualified team of biologists, engineers, technicians, medical experts as well as social and economic science professionals. We offer you support in areas like the delimitation from other device types and the classification of medical devices or IVDs through to the clinical evaluation or performance evaluation. The creation of technical documentation and quality management related tasks - through the support with regulatory issues regarding development, production and placing on the market of medical devices worldwide - are our everyday challenges. MDSS Consulting GmbH is able to provide not only precise urgent assistance but also long-term consulting projects.

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About us

Company details

MDSS specializes in European Regulatory Affairs, your Authorized Representative - your best address!
An Authorized Representative is the main contact for the European Commission and the National Competent Authorities. Appointing MDSS as your European Representative will effectively put your company on the forefront of European Regulatory Requirements.

Our Service
As the European Authorized Representative (EC REP), MDSS is responsible for your products in Europe according to the:

Medical Device Regulation (MDR (EU) 2017/745)
In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746)
Other European Directives & Regulations (RoHS, PPE, etc.)
Our service is an extension of your quality system, fulfilling your regulatory obligations in Europe.

MDSS Provides
MDSS' unique professional expertise on Regulatory Affairs of CE Marking for your Medical Devices includes:

  • Authorized European Address - your best address
  • 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, ISO 13485...)
  • Safety Officer 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

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