On 25 May 2017, the Medical Device Regulation, MDR, became effective. This seminar supports you in meeting the EU regulation's requirements with a minimum of effort.
Upon expiry of the transitional period, all manufacturers, distributors, EU-Representatives and importers of medical devices must comply with MDR's requirements. During this training, you will learn which requirements you and your company must know, understand and meet.
This seminar is a concise introduction into the topics of development, quality assurance and approval of medical software (stand-alone software or medical device software). It especially addresses everyone aiming at getting a quick and comprehensive overview of the following topics:
Hence, this seminar does not only impart comprehensive knowledge to you, but also the skills to rework your quality management system, particularly your processes and specifications, in order to develop your medical devices, to market them and surveil them in compliance with MDR.
|09:00||Beginning of the seminar|
|09:30||Background, regulatory map, amendments at a glance|
|10:00||Actors and roles|
|10:45||Classification and conformity assessment procedure|
|11:30||Safety and performance requirements, technical documentation, "Common Specifications" and harmonized standards|
|13:30||UDI, EUDAMED, Registration|
|14:15||Post-Market Clinical Follow-Up (PMCF), clinical evaluation, clinical trials (upon request)|
|15:15||Post-Market Surveillance PMS, vigilance|
|16:30||Miscellaneous, pending questions|
|17:15||Questions and answers session, typically until 18:00|
We limit the maximum number of participants to 16 to ensure learning success and having enough time to respond to individual questions.
The seminar addresses everyone involved in development for medical devices, especially
The seminar is also suited for beginners and everyone who "just" wants to get an overview of MDR. The trainer will adjust the level of detail the issues are covered depending on the participants' expectations.