Our Academy

We have extensive experience in courses and training delivery.

We can train individuals, groups or whole companies in relevant regulatory requirements, on both general and detailed matters.

We can deliver training at your premises, providing a cost-effective way of training larger groups of people.

We have established course curriculums with proven past results, yet we are just as able to adapt our courses to your specific needs.

When it comes to our academy: we are committed to excellence!

Our courses

Medical Device Sterilisation

The course gives a basic introduction to industrial sterilization of medical devices. The course will focus on the different industrial sterilization methods used for medical ...

Equipment Validation

This course can be conducted as a 1 – 3 day introductory course on equipment validation, depending on the scope of the course. The course ...

Medical Device Documentation

This course covers all the required documentation specified by the Medical Device Regulation (2017/745 & IVDR 2017/746) Annex II and the FDA 21CFR 820.30 Design ...

Good Documentation & Test Practice

The way we prepare our documents can mean the difference between success and disaster! This course goes through all the different Good Documentation Practice rules ...

GMP for Medical Devices

The intention of this course is to give the participants a basic understanding of the fundamental GMP rules within the medical device business, with a ...

Human Factor Engineering – IEC 62366

This course provides a solid introduction to the IEC 62366 standard and the FDA Guidance document within the usability area. We will prepare the key ...

Risk Assessment – ISO 14971:2019

Having a ‘Risk Based Approach’ has been one of the key phrases in the last decade! This course enables the participants to perform FMECA risk ...

MDR & CE Marking Process

Understanding European legislation and the expectations of the authorities is crucial for getting a device on the European market. This course will provide a solid ...

Design Control – 21CFR820.30

This course goes through the different development phases and the different key documents for each development phase; from Design Planning to Design Transfer.