By your side worldwide:
Approval & Distribution for
Medical Devices and In Vitro Diagnostics
Our expertise for your medical devices
MDSS Consulting GmbH is a competent team of experts from various disciplines, including medical technology and biology, with comprehensive expertise in the regulation of medical devices and in vitro diagnostics (IVDs).
We offer comprehensive and customized support for manufacturers, authorized representatives, importers, and distributors, advising them on the relevant regulatory requirements and standards.
Our Services
Quality Management
The introduction of a quality management system according to EN ISO 13485 often marks the beginning of the world of the medical device industry.
Regulatory Affairs
The approval of medical devices is a complex subject that covers a multitude of areas and poses a challenge for those placing medical devices on the market.
Clinical Evaluation
The clinical Evaluation is an essential part of the technical documentation and a prerequisite for the fulfilment of the Essential Requirements.
PRRC
Each medical device or IVD manufacturer and authorized representative must designate responsible person(s) (PRRC – Person Responsible for Regulatory Compliance).
Workshops & Documents
MDSS Consulting GmbH offers workshops for medical device manufacturers.
If you need a specific workshop, please contact us at any time.
Do’s and Don’ts for Distributors/Importers & securing the distributor network for manufacturers.
News
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Attention to the REACH Regulation – Manufacturers, Importers, and Distributors of Medical Devices Are Affected Too!
Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) introduce numerous new require...
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Registration of Medical Devices: How, Where, and by Whom?
Before medical devices can be placed on the market in the European Union, they must be registered...
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Additional Requirements for Importers and Distributor by Authorities
It is no longer new that Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) impos...
Request a free initial consultation now
The free initial consultation includes either a 30-minute telephone call, an online meeting or an on-site meeting at MDSS Consulting GmbH after prior coordination.