Implementing ISO 13485:2016 Webinar

Following an update previously released by UKAS, medical device manufacturers need to transition to the revised version of ISO 13485 by 31 March 2019. Considering that this deadline is fast approaching, medical device manufacturers have to plan and implement their transition. Lloyd’s Register (LR) is delivering a webinar on implementing and maintaining ISO 13485:2016 to help manufacturers ensure a successful implementation.

During the webinar, experts from LR will share the key learnings, main areas of focus, tips for the transition process and an overview of how to maintain an effective management system in accordance with ISO 13485:2016. The webinar is designed for medical device manufacturers who have already transitioned or are planning to transition in the near future.

Date: Wed 25 April 2018
2:30pm (BST)
45min followed by 15min Q&A
John Howlett & Flemming Nielsen

Webinar Speakers

John Howlett, Lloyd's Register Technical Manager – Medical Devices

bhx-image-howlett-iso-13485-webinarJohn Howlett joined Lloyd's Register (LR) as a Technical Manager - Medical in March 2015. He is responsible for all ISO 13485 accreditations and certifications, and he is involved in ISO 13485 training development and activities. Prior to joining LR, John held several positions at BSI including Head of Notified Body.

Widely recognised for his expertise within the medical device industry, John has participated in a wide range of European and UK medical device committees and has been actively involved in the review and implementation of the medical device directives and associated guidance documents. In 2012, John was also selected as an expert witness in the UK’s House of Commons Select Committee inquiry into the regulation of medical implants in the EU and UK.

John is qualified in Mechanical & Production Engineering, has extensive experience in Quality Assurance and has been actively involved as Lead Auditor against the requirements of ISO 13485 since its inception. Over this time, his experience has extended from auditing the largest of corporations through to the smallest of organisations and start-ups.

Flemming Nielsen, Lloyds's Register Technical Specialist – Medical Devices

Flemming NielsenFlemming Nielsen has worked at Lloyd's Register (LR) for 10 years. As a Technical Specialist for Medical Devices, he is responsible for unannounced audits under the MDD and QMS activities “MDD linked to ISO 13485”.

Flemming is currently involved in the assessor training for ISO 13485; prior to his current position, he has worked as an LR Lead Auditor within the MDD, IVDD, CMDCAS, ISO 13485 and ISO 9001 schemes.

Flemming has more than 14 years’ experience in the medical devices industry, and prior to joining LR has worked in quality departments of several medical device manufacturers.

About Lloyd's Register

About Lloyd's Register

LR provides ISO 13485 assessment, certification and training services, and can support medical device manufacturers with ISO 13485:2016 standard certification. We also provide a range of medical directive and CE marking services to help ensure the safety of a range of consumer products and medical equipment. 

LR’s medical assessors have some of the most extensive ISO 13485 experience in the world, and many of them are hand-selected to provide their input to ISO technical committees and the panels reviewing the EC medical device directives. In addition, LR has a distinguished team of microbiologists who assess compliance within the sterile products area as part of a routine QMS assessment.