A good and robust training is the key to familiarize with even the most difficult requirements set up in standards, directives and regulations. It will help you understand the various interpretation that sometimes it is inevitable in the Medical Industry, and overcome the usual fear of “this is too difficult for me to understand”.

It will also allow you to recognize and understand what are the implications of not following specific requirements, especially if you are the Legal Manufacturer and legally and fully responsible for the product(s) on the market.

ALPA Medical expertise can tailor any training to your specific needs. Whether you need a short refresher course, or a beginner course or a more in depth training for the most experienced, I’m sure you will not let down by our fantastic courses.

Quality Management Systems (QMS)

ISO 9001

QMS for Regulatory Purposes (Medical)

ISO 13485

Guidelines for auditing Management Systems

ISO 19011

Risk Management for Medical Devices

ISO 14971

Medical Devices Regulation

2017/745

Canadian Medical Devices Regulation

CMDR

USA Quality System Regulation

21 CFR Part 820

Regulatory Submission for specific markets

Construction of Technical Documentation

Functional Safety for Medical Devices

Auditor/Lead Auditor course

ISO 19011 IN CONJUNCTION WITH ISO 9001 AND/OR ISO 13485 

Usability for Medical Devices

en ISO 60601-1-6 / iso 62366-`

Software Life Cycle Validation

en 62304

Alarms for Medical Devices

EN 60601-1-8