REGULATORY AFFAIRS
Technical Dossiers and CE marking
- Determination and justification of the product status
- Assistance for the classification of the medical device
- Advice for the choice of the conformity assessment procedure
- Identification of the applicable standards and regulatory requirements
- Writing and/or update of the technical file according to Regulation 2017/745
- Assistance for the writing of specific documents (biological evaluation report, clinical evaluation dossier, risk management file...)
- Support for the submission of the dossier to the notified body
- Answers to questions from notified bodies
Specific dossier: Combination products
- Assistance to determine the status of the product (MD or drug)
- Writing of specific related documentation
- Assistance for the submission to the Competent Authorities/Notified Bodies
Advertising
- Regulatory review of promotional material (whether or not submitted to ANSM for prior authorization, various types of material, including websites) according to the French Regulation
- Submission to ANSM for prior authorization
- Assistance for the implementation of a review process and the writing of procedures
Project management
- Identification, management and coordination of subcontractors by dedicated project manager
- Monitoring of the process progress - reporting
Environment
- Definition of your responsibilities as manufacturer for your MDs
- Assistance for the declaration
Quality system
With our partner
- Support for the implementation of the quality system according to ISO 13485 standard
- Preparation of the certification audit by the notified body and inspections by competent authorities
Market Access
With our partner
Pharmaceutical Development
