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 is an introduction course for equipment validation. The course introduces the basic disci- plines within Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification

This course explains all key documents required for each phase of a develop- ment project. This course can also be arranged as 1⁄2-day course.

This course is going through all the documentation rules and explains why these rules are important to fulfil in relation to the safety of the

This course gives the participants a solid knowledge of the different GMP requirements related to the develop- ment and manufacturing of a medical device. This

This course makes participants capable of planning and performing a small HFE study according to IEC 62366 standard requirements.

This course makes the participants capable of performing FMECA risk analysis according to ISO 14971:2019 standard for devices and production equipment. This course includes a

This course is focusing on European approval process and the content of the Medical Device Regulation (MDR), but is also introducing the FDA approval process.

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