Audeline Rath-Lavialle

Independent consultant, I support MedTech startups, manufacturers, and distributors in the compliance and reimbursement of their medical devices, offering them personalized support aligned with their needs.

- CE Marking (EU 2017/745): strategy, technical documentation, support with Notified Bodies

- Clinical: strategy, clinical evaluation plan and report, post-market clinical follow-up (PMCF)

- Reimbursement: strategy, LPPR, LATM, intra-GHS, transitional, PECAN, innovation gói

- Quality: ISO 13485, implementation or improvement, support, audits

- Risk management file ISO 14971

- Post-market surveillance and follow-up, vigilance

- Advertising control and packaging validation.

- Consulting with senior expertise for companies in the medical device sector in Market Access, Regulatory Affairs, and Quality Management

- Carrying out missions related to medical devices in collaboration with manager and operational consultants

- Drafting regulatory analyses or operational mission deliverables;

- Management of the Medical Device Market Access department

- Project and human resource management

- Participation in the company's promotional activities and representation in institutional activities.

- Participation in the development of new services and strategic thinking on company organization

Strategy, consulting, regulatory and quality support from design to post-market.

- EU Regulation 2017/745 on medical devices

- Technical documentation, CE marking, compliance procedures

- Clinical Evaluation Report (CER)

- Risk Management File (ISO 14971)

- Post-market clinical follow-up, vigilance.

- Implementation of quality systems, support, audits (ISO 13485)

- Reimbursement (generic online registration, individual identification code, drafting of brand-name registration files).

- Advertising control and packaging validation.

- Trainer for companies on regulation and quality.

- Participation in the development of programs/schedules and in the animation of inter-company training.

- Preparation of quotes, response to tenders, and client management.

- Recruitment, supervision, and training of collaborators.

- Management of consultants, experts, and partner companies.