How to get your medical devices legally approved ?
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Supply all necessary support to the customer working group assigned to assure the regulatory compliance of the enterprise within the framework of a mandatory project, delivering miscellaneous expertise, consultation, coaching, training and auditing services, relevant to the concerned regulated sector.
Click on the tab Certification to see the distinct services that we proposing specifically for the voluntary projects.
- To coach from A to Z the implementation of a new management system of the quality of the medical devices
To create the content of the management system, tailored to the needs and the enterprise culture of each client
To train the personnel (or the inside trainers) to assure the effective maintenance of the system
To pre-audit the obtained results in order to rectify the last deviations
To submit the rectified results to the concerned Authorities in order to obtain the required permit or license
Proposed reference models:
ISO 13485: International requirements for regulatory purposes - Medical devices
CMDCAS: Specific mandatory requirements of Health Canada
SOR/98-282: Medical Devices Regulations, class I to IV
FDA 21CFR820.1: Requirements of the Food and Drug Administration (USA)
European Directive 93/42/EC, amending acts and related regulations
Any other reference models whose implementation must be documented and demonstrated before to obtain the legal permission to engage the enterprise in a regulated activity.