Biocompatibility, Cleanliness and Sterilization, and Clinical Evaluation

SGS Academy in Finland will organize a training

Biocompatibility, Cleanliness and Sterilization, and Clinical Evaluation 

Date and location:

October 4th, 2023

9 am – 4:30 pm (Registration and breakfast starting 8.40 am)

Juju Kampus, Takomotie 8, 00380 Helsinki

Introduction:

Biocompatibility, Medical Device Cleanliness and Sterilization Requirements, and Clinical Evaluation. For each medical device, regardless of the classification, technical documentation must be drawn up, which can be used to demonstrate to the supervising authority or notified institution that the requirements are met. Technical documents must demonstrate that the medical device complies with both the manufacturer's own and statutory requirements. The technical documentation as a whole includes demonstrating the tissue compatibility of the device using prevailing approved methods. Some of the devices have special cleanliness or sterilization requirements, which must also be taken into account in the technical documents of the devices.

In this training, we go through the biocompatibility, medical device cleanliness and sterilization requirements, and clinical evaluation set by the MDR.

Registration:

Please register by September 18th, 2023 at the latest.