courses

ISO 13485:2016 Medical Devices, FDA, EU MDR, & MDSAP

Why was ISO 13485 revised?

ISO 13485:2016 sets out the requirements for a quality management system specific to the medical devices industry. It has recently been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry.

 


What does ISO 13485:2016 include?

With the standard applicable to so many types of products, the revision was no easy task. A medical device is any product intended for use in the diagnosis, prevention and treatment of medical conditions. They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines and diagnostic reagents.


How is the new ISO 13485:2016 better?

Improvements in the latest version of the standard include broadening its applicability to include all organizations involved in the life cycle of the product, from concept to end of life, greater alignment with regulatory requirements, and a greater focus on post-market surveillance including complaint handling.

There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.

Read more on ISO.org

Axeon is an Exemplar Global Certified Training Provider.

Early Bird Pricing

Lead Auditor Training Course

Online-Virtual Classroom

4 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 13485 Lead Auditor Training Exemplar Global TPECS Certified

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Lead Auditor Certification in Medical Device Quality Management Systems.

Lead Auditor Training Course

4 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 13485 Lead Auditor Training Exemplar Global TPECS Certified

 

3 Day Schedule: 7:30 AM – 4:30 PM MST

 

Audience: Beginner to Advanced
Process and Software Validation Training RTP Certified by Exemplar Global

 

We teach you how to use auditing to improve your organization

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.4
Audience: Beginner to Advanced
MDSAP Training Examplar Global RTP Certified

Internal Auditor Training Course

 

3 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 13458 Internal Auditor Training TPECS Certified

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

Internal Auditor Training Course

 

3 Day Schedule: 7:30 AM – 5:30 PM MST

 

Audience: Beginner to Advanced
ISO 13485 Recognized by Exemplar Global

Axeon is an Exemplar Global Certified Training Provider. This course is recognized by Exemplar Global as meeting the knowledge requirements for Internal Auditor Certification in Medical Device Quality Management Systems.

For Medical Device Manufacturers

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.5
Audience: Beginner to Advanced
IVDR Training Recognized by Exemplar Global

The European Regulation 2017/746 related to In Vitro Diagnostic Devices (IVDR) is in effect and companies must make the transition to the new regulation by May 26, 2022.

Under the IVDR, all currently approved in vitro diagnostic devices must be recertified in accordance with the new requirements. There are no grandfathering provisions, so it is time to help your organization understand this regulation. 

For Medical Device Manufacturers

 

3 Day Schedule: 7:30 AM- 4:30 PM MST
CEU Hours: 2.5
Audience: Beginner to Advanced
EU MDR Training Recognized by Exemplar Global

 

Days: 2

Time:  7:30 AM- 4:30 PM MST

AXEON’s training courses begin with your objectives in mind. Before any training begins the instructor must have an objective to deliver your desired outcome. If the course does not have a specific objective, students can go through the motions with little added value. AXEON’s course setup begins with a candid discussion of your needs and expectations with the course instructor to develop specific areas of focus for the class. Below is a general outline for the course and topics that will be covered.

Application of risk management to medical devices

 

3 Day Schedule: 7:30 AM – 4:30 PM MST

 

Audience: Beginner to Advanced
ISO 14971 Recognized by Exemplar Global

Days: 2

Time: 7:30 AM- 4:30 PM MST

Audience: Beginner to Advanced

Days: 1

Time: 7:30 AM-4:30 PM MST

Audience: Top management