ICH GCP R2, ISO 14155, EU Medical Device Regulation instead of Directives and MEDDEV guidelines all provide either guidance on or regulate the medical device research field. European organizations like EUCOMED and MedTech represent the medical device business to ensure regulatory compliance and increase the European competitiveness with other global regions. All this information can cause the device researcher to wonder what to follow and when and how to ensure compliance.
This TRIUM Training provides clarity by explaining the differences between guidelines, directives, standards, requirements and regulations and by providing an update on the key sponsor and investigator responsibilities. Lecture is held to a minimum, instead many opportunities for sharing ideas, examples and case studies are built into the design to ensure peer to peer learning and knowledge retention. Therefore, participants will not only be able to repeat what they learned but will also be able to find information when needed and apply it immediately to ensure trial oversight, compliance and audit readiness at any time for themselves and their business partners like vendors or consultants.
At the end, you will receive a certificate for attendance and handy hand-outs for use in the field.
By the end of this TRIUM Training you should be able to:
- Describe the difference between a guideline/guidance document, standards, requirements (e.g. ISO) and a regulation
- List the sponsor and investigator responsibilities as per ICH GCP R2, ISO 14155, the European Directives/MEDDEV guidelines (2.7.1 rev4) and the EU Medical Device Regulation
- List the EUCOMED device trial related requirements
- Find the device related guidelines and regulations by using the official regulatory body website of the EMA or ISO and by using the EUCOMED/MedTech/MEDDEV websites
- Ensure trial oversight for the sponsor and its business partners to ensure compliance and audit readiness at any time
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.