Duration: 45min followed by 15min Q&A
Speakers: John Howlett & Flemming Nielsen
With the revised version of ISO 13485 published in March 2016 and considering that we are now well into the transition process, all medical device manufacturers are advised to start their transition immediately if they haven't already done so.
As all new certifications and re-certifications must be to ISO 13485:2016 after 1 March 2018, LR offers a webinar to help medical device manufacturers understand & implement the main changes introduced.
During the webinar, experts from LR explain the main elements of the ISO 13485 revision and guide manufacturers on how to determine their readiness for assessments against the revised standard, in order to ensure that their plans are aligned to achieving certification within the defined timescales.
Background to the revision and its relationship with ISO 9001
- Key changes within the ISO 13485:2016 revision
- Main points and emphasis of the revised standard
- Determining the readiness of your organisation
- Implementation – Timescale & challenges
John Howlett, LR Technical Manager – Medical Devices
John Howlett joined 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 LRQA, 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, LR Technical Specialist – Medical Devices
Flemming Nielsen has worked at 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.
LR provides ISO 13485 assessment, certification and training services, and can support medical device manufacturers with a smooth transition to the revised ISO 13485:2016 standard. 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, LRQA has a distinguished team of microbiologists who assess compliance within the sterile products area as part of a routine QMS assessment.