This is the online ISO 13485 training you need to carry out effective internal audits.

See the ISO 13485 training you need to carry out effective internal audits here.

Our ISO 13485 Lead Implementer is ideal for you.  You may need some consultancy support on implementation, but that should be limited. Furthermore, you’ll know the ‘right’ questions to ask.

Implementing a Medical Device Management System yourself can be challenging. However, it’s a great way to quickly introduce changes needed to secure and retain ISO 13485 certification.

You’ll be an ISO 13485:2016 Lead Auditor with this 24-hour Conversion Course.

With this 24-hour Extension Program you will become a certified ISO 13485:2016 Lead Auditor.

Provides in-depth knowledge of the Standard and of Auditing skills. This is the certification you need if you hope to audit for a Certification Body.

This Transition Training package includes an ISO 13485: 2016 Implementation Handbook. Packed along with it is a documentation toolkit, lots of sample paperwork, and a Gap Analysis Tool.

For Consultants

With this 24-hour Extension Program you will become a certified ISO 13485:2016 Lead Auditor.

Includes a 33-step Path to Certification, a 100+ page ISO 13485: 2016 Implementation Handbook.

It also includes a Documentation Toolkit that contains sample SOPs and record forms. Examples of audit schedules and management review agenda are included as well.  Truly beneficial to a new MDMS consultant.

With this 8-hour Conversion Course, you’ll become a certified ISO 13485: 2016 Internal Auditor. Moreover, you can get it at a fraction of the usual time and cost it takes to finish the course.

With this 8-hour Extension Course, you will become a certified ISO 13485:2016 Internal Auditor,