TOPRA in Scotland - Medical Devices & In Vitro Diagnostics

TOPRA in Scotland - Medical Devices & In Vitro Diagnostics
TOPRA in Scotland would like to invite members and non-members to a presentation on Medical Devices and In Vitro Diagnostics.






Registration is now open for the next TOPRA in Scotland meeting.

Please note that this meeting will be in-person only and not be held as an open webinar. Light refreshments will be provided. 

Date: Wednesday 12 June 2024

Time: 14.00-17:00 GMT

Venue: The Sir Arthur Conan Doyle Centre, 25 Palmerston Place, Edinburgh, EH12 5AP.

SPEAKERS

IVD/MD use in clinicals under the ever evolving/changing requirement in the UK and EU
Marcia McNicol, Principal Consultant  - JEMMDx

Marcia McNicol is a business leader with hands on industry experience for over 25 years, directing and leading teams to develop and commercialise many products in that time. After leaving LumiraDx in 2023 Marcia is now a consultant with MCN Compliance Ltd and JEMMDx Limited, providing consultancy service focused on patient-centric diagnostics:  Point of care tests, Consumer Diagnostics, and FemTech.

Understanding the requirements for Article 117 for MDR & IVDR
Angela Paterson, Principal Consultant  - Compliance Solutions (Lifesciences) Ltd

Angela is a Bioscientist/ Microbiologist with extensive experience of working in the Life Sciences and Medical Devices Industry for over 25 years with proven expertise in regulatory affairs, quality, and validation.  She has experience working with regulatory agencies e.g. Notified Bodies, MHRA, US FDA, Health Canada, and Japanese PMDA. 
 
Angela is Principal Consultant at Compliance Solutions and has worked with many clients including, Neurovalens, Vascular Flow Technologies, Current Health, Teleflex, OSSDsign, Kuros Biosciences, Axis Spine, Spineway, Sure Ltd. CardioPrecision, Brightwake, Arrayjet, Flex Medical Solutions. Angela has worked with all classes of device from active to implantable, including custom devices.  These roles involved the preparation of European (CE Marking) and US FDA Regulatory (510K, PMA, IDE, Presub) submissions, development and implementation of quality systems to ISO 9001, ISO 13485 and the US FDA Quality system regulations.
 

Pricing

  • TOPRA Members: Free  
  • Non-member: £45 (includes 2 months TOPRA membership)

 

How to register

Members:

  • Use the 'Register now' form above to log in to the site with your TOPRA Member username and password.
  • Once logged in click the 'Register Myself' button that will appear below.

Non-members:

  • If you already have non-member account for this site, log in and then click the 'Register Myself' link that will appear below.
  • If you do not have an account, create an account, then log in and click the 'Register Myself' link that will appear below.

Registration is free for TOPRA members and Non-members can register for £45 (which includes two months of TOPRA membership). Student membership of TOPRA is free and is available to full-time undergraduate students. 
 
When
12/06/2024 14:00 - 17:00
Where
25 Palmerston Place Edinburgh EH12 5AP UNITED KINGDOM
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