ADEQUAT EXPERTISE collaborates today with companies which need simple and practical solutions to implement, in coherence with their strategy of development, their size and their economic constraints:
Some examples of achievements
- Full management of a quality and regulatory department, company which designs and manufactures medical devices for digestive surgery, breast surgery and dental surgery, class III medical devices utilizing animal tissue.
- Diagnostic and implementation of GMP 21 CFR PART 820 requirements, company which designs and manufactures class IIa sterile surgical instrumentation.
- Full audit of a quality management system according to ISO 13485 and 21CFR Part 820 standards, company which designs and manufactures sterile orthopedic instrumentation.
- Training related to new European regulation 2017/745, company which manufactures sterile implantable medical devices
- Assistance for the CE Marking of sterile implantable medical devices, class IIb, company which designs and manufactures orthopedic implants.
- Transition to the new regulation 2017/745.
- Preparation to FDA Inspection, company which designs and manufactures sterile surgical instruments.
For more details, download our references