MDSS Consulting GmbH
Your Partner for Medical Device Registration
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.
Our area of activity at a glance
- Medical Device Regulation (EU) 2017/745
- In-vitro-Diagnostics Regulation (EU) 2017/746
- other European Directives & Regulations (ROHS, PPE, etc.)
Our Services
- Quality Management
- Regulatory Affairs
- Clinical Evaluation
This includes, among others:
We support you all the way, from delimiting your product against other product types, through classifications of medical devices / IVDs, to clinical evaluations / performance evaluations. Our daily challenges include creation of technical documentations and various tasks in the quality management area – up to support with regulatory questions concerning development, manufacturing and placing on the market of medical devices worldwide.
Furthermore, our service includes carrying out internal audits and support with external audits and authority inspections.
MDSS Consulting GmbH offers both precise emergency assistance and long term consulting projects.