UKCA Medical Devices - are you ready for the future?

What will the webinar cover?

The deadline for UKCA marking is fast approaching, with many medical device manufacturers still not applying for UKCA certification. This webinar will give an insight into the current state of play and lessons learnt from an approved body perspective.

We will also touch on with the status of the new UK legislation and what this may entail. The importance of submitting applications to an approved body will also be discussed and an overview of the process will be explained. 

Who should attend the webinar?

This webinar will offer approved body insights for all people involved in working towards a UKCA application, whether you are a novice or have more significant experience of working with an approved body.

What will participants gain?

• Insight into the current UK legislation for medical devices.
• The future of the UK legislation.
• Approved body insights into applications for UKCA.

Vishal joined BSI over 6 years ago and is currently the Head of the UK Approved Body and a Senior Regulatory Lead for Medical Devices. He is responsible for the regulatory oversight of the Medical Devices Approved Body and wider BSI strategy, policies, procedures, and documentation to meet the various legislative and designation requirements. Prior to his current role, he has been a Regulatory Lead, Technical Team Manager, Technical Specialist & Scheme Manager with expertise in Active Devices.

Vishal holds a Masters in Medical Engineering from Queen Mary University of London and has over 10 years’ experience with medical devices working within industry, third party testing and Notified/Approved Body.

Graeme is Senior Vice President, Global Regulatory and Quality, Medical Devices at BSI. He has responsibility for BSI’s regulatory compliance to undertake a range of global medical device certification and accreditation activities.

Prior to joining BSI, Graeme was Director of Devices at the UK Medicines and Healthcare products Regulatory Agency (MHRA), where he was responsible for ensuring the safety and performance of medical devices in use in the UK. Graeme first joined the MHRA in 2011 and spent much of his time at the MHRA negotiating and implementing a package of measures to strengthen the regulation of medical devices.

Graeme was a civil servant for nearly 20 years and spent his early career working on healthcare policy. He has previously held Deputy Director roles at the Department of Health and Social Care and spent 18 months as Private Secretary to the Secretary of State for Health.

Graeme has a Master’s degree in biochemistry from the University of Oxford. 

Maddalena holds a master’s degree in medical biotechnology and has over 13 years of experience gained both within industry and Notified/Approved Body.

During her industry career, she developed and executed regulatory strategies to secure regulatory approvals on a global scale, translating regulatory requirements into project/product requirements.

In her current role in BSI, working along with the Heads of the Notified Body and Head of the UK Approved Body, she develops processes and procedures to ensure compliance with the various legislative and designation requirements.