Informative BSI white papers
White paper: How to best prepare for and implement the IVDR - Dos and Don'ts
This white paper from BSI guides you through the IVDR legislative changes. This useful paper provides a checklist, allowing you to see how the Regulation will impact on current manufacturer operations and what you need to consider before the Regulation comes into force, both during the transition period and after it is implemented. Co-Authored by Dr Gert Bos, former Head of Regulatory Affairs at BSI, and Erik Vollebregt, Partner at Axon Lawyers, the white paper is the most recent in a series from BSI to support you through the transition from the IVD Directive to the IVD Regulation.
Download your copy now.
White paper: The proposed EU regulations for medical and in vitro diagnostic devices
An overview of the likely outcomes and the consequences for the market, updated October 2015
To understand how the changes will impact the industry, and what this means for your business, download your complimentary copy of BSI's updated white paper. Authored by Dr Gert Bos, Head of Regulatory and Clinical Affairs at BSI, and Erik Vollebregt, Partner at Axon Lawyers, the white paper provides insight into the likely outcomes of the Regulations consequences for the market. Don't delay in understanding the consequences of these significant, mandatory changes on your business.