UKCA Marking: What is needed for medical and IVD device manufacturers

Join our complimentary webinar and gain an overview of the UK Conformity Assessment Scheme (UKCA) for medical devices, an update on UK medical device regulations and what medical and IVD device manufacturers require to be able to place devices in the UK market with UKCA marking.

Date: 29 March 2022
Start Time: 10:30am
End Time: 11:30am

Agenda

• Introductions
• Status of UK medical device regulations and future developments
• What is needed for UKCA marking and access to the UK market
• How SGS UK Approved Body (AB0120) can help you
• Q&A

Registration

Please click here for registration.

Presenters

Sharon Williams
UKCA Medical Devices Certification Manager, SGS United Kingdom Ltd

Sharon has 20 years’ Notified Body experience including auditing, training, and managing global accreditation to carry forward to the UK Approved Body. She has experience with ISO 13485, IVD MD Directive 98/79/EC and the Medical Devices Directive 93/42/EEC, as well as the new regulations (EU) 2017/746 (IVDR) and (EU) 2017/745 (MDR).

She is now responsible for the UK Conformity Assessment (UKCA) scheme for both medical devices and IVDs. Prior to joining SGS, Sharon worked in the IVD medical device industry sector for over a decade.

Roger Vokins
UK Medical Devices Operations Manager, SGS United Kingdom Ltd

Roger joined SGS United Kingdom Ltd in 2010 initially as part of the general admin team covering medical devices, PPE, CRS and retail schemes. Roger later joined the global medical devices team to help establish the administration functions and affiliate monitoring activities. In January 2016, having successfully completed in-house training to the equivalent level as a medical devices auditor (ISO 13485 & 93/42/EEC), Roger moved to the UK team as the administration team leader. Over the past decade Roger has developed his skills as a technical approver and is now the UK Medical Devices Operations Manager with ISO 9001:2015 auditor status.

Lynette Wilson
Key Account Manager (Medical and Pharma), SGS United Kingdom Ltd

Lynette joined SGS seven years ago as the UK Operations Manager for key accounts and performance assessment. She now specializes in business development and key account management for new and existing clients seeking certification and product conformity assessment for medical devices, along with GMP and GDP for pharma and cosmetics.

Prior to joining SGS, Lynette worked for over two decades in training provider organizations, managing commercial and funded contracts for the provision of young people and adults’ education and training services.

Target Audience

This webinar is for medical and IVD device manufacturers who are based in or outside the UK but want access to the UK market for their products.

Language: English
Cost: No charge

Can't make the live session? Register now and receive a complimentary recording after the live event.

For more information, please contact:

Yemisi Olutogun
Business Support
t: +44 (0)1276 697 715
e: uk.nowisthetime@sgs.com