Regulatory Support

MD101 can help you register your products and obtain CE marking, FDA Clearance or registration
on other markets.

Services and expertise > QARA > Regulatory Support

Ask for a quote

Sélectionnez les domaines d'activité qui vous intéressent parmi nos offres de service :

QARA

Representative in the European Union Cybersecurity Artificial Intelligence Digital medical devices Regulatory Diagnosis Regulatory monitoring Internal audit Regulatory Support External PRRC Quality Management System

Clinical & reimbursement

Reimbursement Strategy Clinical Evaluation

Operating partner

Investment Strategy Corporate Strategy

Business & marketing

Innovative Medtech Marketing : Europe vs. United States Market Prioritization International Development Strategy
* required field * required field * required field * required field - thanks for entering a valid email * required field
Send your request
* required field By clicking on the send button, I confirm that I have read and understood the privacy Policy. Subscribe to MD101 newsletters

To get your medical device to market faster

Qualified experts, a customized solution :

  • Support in ensuring that your device complies with applicable regulatory and standards requirements.
  • Conducting risk analyses and helping you compile risk management files.
  • Support in drawing up technical documentation for CE marking.
  • Support for your registration : as a manufacturer, your devices are registered in EDAMED and the UDI positioned on your product.
  • Review and assistance in bringing your technical documentation in line with regulatory and standards requirements.
  • Assistance with the preparation of registration dossiers for the FDA, Health Canada or other national regulations.

MD101 is registered as an expert with BPI (French Public Investment Bank). Our support in setting up a technical dossier may be covered by the BPI’s medical device diagnostic aid scheme.

MD101, co-founder of the .emt Alliance

United to support companies in HealthCare

MD101, co-founder of the .emt Alliance

MD101, founding member of The MedTechAlliance, USA

Catalyzing global growth and innovation

MD101, founding member of The MedTechAlliance, USA