Global Consulting Services for Medical Device & IVD Companies
Regulatory & Clinical Strategy Consulting
MDSS Consulting GmbH supports you in navigating the complex regulatory requirements for medical devices and in vitro diagnostics (IVDs) worldwide (e.g., in USA, Australia, New Zealand, Switzerland, United Kingdom etc.).
Our experienced team offers tailored consulting to ensure your products meet the relevant requirements and achieve successful market access.
FDA QMSR Rule Gap Assessments
With the new FDA Quality Management System Regulations (QMSR) coming into effect on February 2, 2026, we offer comprehensive gap analyses to facilitate the transition from 21 CFR 820 to ISO 13485.
510(k) & De Novo Strategy and Preparation
Leverage FDA pre-submissions to address critical points in advance.
We provide:
We provide:
- Strategic planning for 510(k) and De Novo submissions;
- Preparation of comprehensive submission dossiers;
- Consulting on regulatory pathways for expedited approvals.
Support with FDA Interactions
Engage effectively with the FDA throughout the product lifecycle.
Our support includes:
Our support includes:
- Preparation for pre-submissions;
- Assistance during FDA inspections;
- Ongoing communication to address regulatory inquiries.
U.S. Agent
MDSS USA LLC acts as your U.S. Agent, a significant component of U.S. requirements for medical devices and IVDs manufactured outside the USA.
What international expertise do we provide?
- For Switzerland (SWISSMEDIC), United Kingdom (MHRA), USA (FDA), Australia (TGA), as well as other countries outside EU: Developing customized regulatory strategies to meet specific requirements, ensuring successful approvals and ongoing compliance.
- Clinical Strategy Development: Designing and implementing clinical strategies to support the minimum requirements for product approvals.
Do you need support with international market access?
We look forward to hearing from you and working together to find the right path. Request a free initial consultation*.