On this episode, I was joined by Richard Houlihan, CEO of Eirmed. Richard and I discuss:
- History of Eudamed (Starting with EU Legislation in 2010)
- The 6 modules of Eudamed (PMS, Vigilance & Post-Market Surveillance, Clinical Investigations, Certificates, Market Surveillance, Actor Registration)
- Responsibilities for Economic Operators (Manufacturers, Importers, Authorised Representatives, System and Procedure Packs)
Richard Houlihan is the CEO of Eirmed, a company focused on helping companies achieve compliance with the EU Commission EUDAMED requirements including training, software, data preparation and processing, and support. He has been in the IT space for more than 25 years with almost 10 of them with the EU Commission. He can be reached at eudamed.com.