Regulatory Consulting for Medical Devices & IVDs

Supporting you worldwide

Navigate the complexities of medical device and IVD regulations with a single trusted partner. MDSS Consulting GmbH offers comprehensive support—from initial strategy development to market launch and beyond—ensuring your products meet applicable requirements and reach the market efficiently.

Our services

Quality Management

EN ISO 13485
MDSAP
GMP
FDA
Audits
...

Regulatory Affairs

MDR /IVDR
FDA
Technical documentation
PMS
Certification
Conformity
Vigilance
...

Clinical Evaluation

CEP
CER
Analysis
Clinical Data
...

PRRC

Responsible Person
Compliance
Technical documentation
Vigilance
...

EUDAMED

Actor registration
Product registration
Vigilance
Interactive support
Data collection
...

Approval & Registration

EU (Italy, Portugal, Spain, etc)
Switzerland
UK
USA
Australia
New Zealand
...

EU

News

Workshops & Events

MDSS Consulting GmbH offers workshops and training sessions for all economic operators.

If you require a specific event (e.g. in-house or online seminar), please feel free to contact us at any time.

Document-templates

Downloads

Don’t let regulatory complexities hold you back.

Request a free initial consultation*.