ABHI Seminar: Changes to ISO 13485 and Compliance with the MDR
10:00 AM - 16:00 PM
Do companies ‘get-it’, when it comes to implementation of the MDR and the new quality management standard EN ISO 13485:2016? It is feared by some commentators that in the same way that Brexit is creating confusion for UK manufacturers through uncertainty, the overlap of quality and regulatory compliance during the three-year transition period of the new regulation, may be doing the same.
Misunderstandings as to the timelines required for notified bodies to be designated as ‘competent’ to certify companies under the new regulation, suggests that medical devices requiring assessment by a notified body may not commence until at least May or June 2019. However, certification to the new quality management system standard is required by the 28th February 2019. As a result, neither notified bodies or certification agencies will be able to support auditing and certification against EN ISO 13485:2012 after 28th February 2019.
ABHI are therefore addressing this topic on 12th April 2018 at a one-day conference. Key experts from industry, standards bodies and the competent authorities are coming together to discuss topics such as:
- The challenges of the new standard
- How large and small companies implement the standard
- Common pitfalls of auditing
- Quality considerations in the new Medical Device Regulation
- Competent authority expectations
- The role of the Standards body.
To answer these critical questions, do not miss this opportunity to quiz those people who have written, implemented, and audited arguably the industry’s most important route to regulatory compliance.
I had the opportunity to meet with key NHS suppliers under the umbrella of ABHI where we opened a dialogue about service quality, innovation and value management.Lord Carter of Coles (Patrick Carter) (Chair of NHS Procurement and Efficiency Board )