Our courses

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 ...

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

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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