Regulatory Consulting & Audits
Concrete solutions, tailored to your challenges
At Certeafiles, we support you in your compliance processes with a rigorous, clear, and results-oriented approach.
Our approach
Each mission is built on a tailored basis according to your context, priorities, and level of regulatory maturity.
Our objective: make regulation more accessible so you can move forward with confidence.
Our areas of intervention
Regulatory compliance
- Analysis of applicable requirements
- Support for assembling the technical file
- Interaction with notified bodies or competent authorities
Internal audits & audit preparation
- Conducting internal audits (ISO 13485, MDR)
- Preparation for notified body audits
- Compliance review and action plans
Quality management systems
- Creation or update of your ISO 13485 QMS
- Integration of Regulation (EU) 2017/745 requirements
- Preparation for certification
Targeted technical topics
- Software as a Medical Device (SaMD)
- Risk analysis (ISO 14971)
- Clinical evaluation, PMCF, PSUR
- Market entry strategies
A specific need?
We also handle one-off subjects with responsiveness and clarity.
Why choose Certeafiles?
- A team from the medical device sector
- Structured methods, compliant with authority expectations
- A pragmatic, results-oriented support that transfers knowledge
Available trainings, as a complement
Need to strengthen your skills? Our Qualiopi-certified trainings can effectively complement your support.
Download the catalog