Certification: Medical Devices - Quality Management Systems (ISO 13485)

ISO 13485:2016 is an independent quality management system (QMS) standard based on the globally acknowledged ISO 9000 series for quality management. It customizes the ISO 9000 process-oriented model to suit the controlled environment of medical device production.
More information about this certification

More than two years of education or training after high school required?
No
More than two years of work experience required?
Yes
Oral or Written Exam Required?
Yes
Renewal Required?
Every 3 Year(s)
Renew through Continuing Educational Units(CEU)?
Yes
Renew through Re-Examination?
Yes
Renew through Continuing Professional Development(CPD)?
No
Does applicant have choice of at least two options from above for renewal (CEU, CPD, or exam)?
Yes

On Site

Certification courses are taken in seminars, more information can be found here:

http://www.iapmodwbp.org/hidden/general-class-information/

Advanced

The certification has an education level of an Associates of Arts or Associates of Sciences degree or higher and has a work experience requirement of more than 2 years, or requires obtaining a ‘core’ level certification from the same organization.