Regulatory Affairs
ADEQUAT EXPERTISE assists manufacturers in their new product development projects, to meet essential regulatory requirements and to market their medical devices on the international market.
ADEQUAT EXPERTISE also helps manufacturers to better understand the different evaluation procedures and can intervene in the design process in order to write all the technical elements necessary for the marketing of medical devices.
Areas of expertise
- EC marking
- European Regulation (EU) 2017/745 related to medical devices
- Technical file
- Medical devices utilizing animal tissue (ISO 22442 series)
- Risks management (ISO 14971 – ISO 62366 – ISO 22442-1)
- Medical devices / software (ISO 62304)
- Procedure 510[k]
- Post-market surveillance
- Post-market clinical follow-up
- Vigilance systems (EU – US) : 21CFR Part 803 / 21CFR Part 806
- Clinical evaluation and clinical studies (MEDDEV 2.4 / ISO 14155)
Services
- Assistance for placing medical devices on the market
- Assistance for new regulation transition
- Assistance for writing technical file
- Evaluation of the conformity to regulatory requirements
- Diagnostic
- Regulatory audit
- Preparation to inspections ANSM / FDA
- Training
