United Kingdom Conformity Assessed (UKCA) Marking for Medical Devices Training Course

DUBLIN, June 29, 2023 /PRNewswire/ -- The "UK Conformity Assessed (UKCA) Marking for Medical Devices Training Course" conference has been added to  ResearchAndMarkets.com's offering.

With the June 2023 UKCA mark deadline rapidly approaching, the challenges facing Medical Device companies, Regulators and Conformity Assessment Bodies are growing. The requirements for this new UKCA mark will impact technical documentation, labelling, logistics and regulatory compliance.

The steps you need to take to prepare for the UKCA marking will depend on the current status of your business and your future market access requirements.

This seminar will provide UK and global companies practical guidance on what you need to do to continue market access or gain market access with your medical device in the UK after June 2023.

Benefits in attending

•  Understand the requirements to achieve UKCA
• Know the differences between UKCA and CE marking
• Learn how to align your conformity assessment procedures to meet UKCA and CE marking requirements
• Consider the requirements for the Northern Ireland market

Who Should Attend:

• Medical device professionals who wish to gain knowledge and understanding of the new UKCA requirements
• Regulatory affairs managers
• Medical device manufacturers
• Business development managers

UKCA Marking and your legal obligations

• The UK Medical Device Regulations explained
• The use of standards in the UK
• UK guidance for medical devices

UKCA Marking explained (placement of UK CA Mark)

• Registering as a manufacturer to sell medical devices in the UK
• Registering medical devices in the UK
• The role of the UK Responsible person
• UK Conformity Assessment Bodies

Technical Files and UK Declaration of Conformity

• UKCA Technical File Versus EU Technical Documentation, differences and similaraties
• Aligning your conformity assessment procedures

UKNI Marking and the future

• The process in Northern Ireland
• Proposed future changes to UK regulations

Workshop - Case Study on obtaining the UKCA Mark

• Case study on obtaining the UKCA Mark

Workshop feedback

Q & A

Speakers:

Tina Amini
Pharmacist
Aston University

Dr. Tina Amini is a pharmacist with a PhD in Pharmaceutics from Aston University. She joined Lloyd's Register as Senior Technical Specialist in 2018. She has previously worked at BSI as the lead Pharmaceutical Expert and Combination Product Specialist for several years.

Tina has been involved in the classification of borderline products and consultation process with several EU competent authorities for device/drug products. Prior to joining Notified Bodies, Tina worked in the Pharmaceutical Industry for over 17 years in a variety of disciplines where she took products through from discovery to commercialisation.

Janette Benaddi
Director of Clinical & Consulting Europe
NAMSA

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years' experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she ahs also provided training to Notified bodies in this subject.

Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies.

For more information about this conference visit https://www.researchandmarkets.com/r/4928r9

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