Medical Products Supplies Companies

Schiffgraben 41, 30175 Hannover
Germany
Telephone +49 511 62628630
Fax +49 511 62628633
info@mdss.com
http://www.mdssar.com

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07 Medical Services and Publications
07.10 Consulting services for health organisations

Consulting services for health organisations

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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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