Aurore Ametis

Independent consultant specializing in Quality and Regulatory Affairs for medical devices, with over 9 years of experience in supporting management, compliance piloting, and quality system optimization.

I work with manufacturers, distributors, and start-ups to:

✔ Implement, optimize, or maintain Quality Management Systems compliant with ISO 13485

✔ Structure and secure technical documentation (MDR 2017/745, IVDR)

✔ Prepare, conduct, and follow up on internal and supplier audits, and provide support for certification and CE marking audits

✔ Support teams in risk management (ISO 14971), document control, and key processes

✔ Ensure end-to-end regulatory compliance: PMS, vigilance, clinical evaluation, regulatory strategy

✔ Train employees on Quality & Regulatory requirements to enhance internal autonomy

My approach: pragmatic, structured, and results-oriented, with a real focus on team efficiency and alignment with regulatory requirements.

✔ Consultant on ISO certification and CE marking projects

✔ Operational company support

✔ Outsourcing of Quality and Regulatory functions for companies

✔ Outsourcing of PCVRR functions

✔ Training / awareness raising ✔ Clients: Manufacturers of sterile devices, equipment, software, e-health, Distributors, Testing laboratory

REFERENCES

Support in drafting technical documentation compliant with Regulation 2017/745 and PCVRR function. Medical Device Software Start-up