The ISO 13485 Master certification is a professional certification for professionals needing to implement Medical Devices and to master the audit techniques and to manage (or be part of) audit teams and audit program.
The principal competencies and knowledge skills needed by the market are the ability to support an organization in implementing and managing Medical Devices as specified in ISO 13485:2016 as well as manage an audit program.
Various professions may apply for this certification:
• Senior manager or senior consultant wanting to implement medical devices
• Senior project manager or senior consultant wanting to master the medical device implementation process
The requirements for this certification are:
|Credential||Exam||Professional experience||MS audit/ assessment experience||MDMS project experience||Other requirements|
|ISO 13485 Master||PECB Certified ISO 13483 Lead Auditor exam or equivalent, and PECB Certified ISO 13483 Lead Implementer exam or equivalent||Ten years: Six years of work experience in related field||Audit activities totalling 500 hours||Project activities totalling 500 hours||Signing the PECB code of ethics|
Informations and registration:
Alexandra Niculae, Training Director ENVISO