Primeiro NB designado para o MDR – BSi UK http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
Posts published in January 2019
Interesting read from BSI – Want to know more about the Notified Body?
Interesting read from BSI – MDR Documentation Submissions Best Practices Guidelines
Interesting read on meddeviceonline – How To Avoid Compliance & Timeline Risks When Selecting A Medical Device Supplier
Interesting read on meddeviceonline – Understanding Costs And Risks For HFE Usability Studies — Part 1: Testing In-House
MDR and IVDR implementing measures rolling plan – December 2018
Guide for referencing standards in public procurement in Europe (JIS Action 11)
Commission reply to a Petition “For a Compensation Fund for PIP Breast Implants and CE” from the website change.org
TGA Consultation: Good Clinical Practice Inspections Program
Texts of ANVISA CPs 584, 585 and 585 are available. Comments and suggestion until March 9th. Disponibilizados textos das CPs 584, 585 e 585 da…