Notre série Clinical Masterclass est de retour!

Date: 11 Janvier 2023

Performing a robust clinical evaluation plan is a critically important step and if not done correctly can undermine your overall clinical evaluation. In this webinar attendees will understand the critical steps and how to successfully document a clinical evaluation plan including the new MDR requirement of the clinical development plan.

Date: 25 Janvier 2023

Preparing a good quality clinical evaluation report (CER) for submission to the notified body is vital to ensure that the notified body understands your device and the data you hold. This session will look how best to document the contents of a CER and this first session in the two part series will consider the notified body’s expectations in the conduct and documentation of literature searches.

Date: 8 Février 2023

This webinar is the follow up webinar to ‘Preparing a Clinical Evaluation Report (Part I)’. In this webinar, attendees will understand how best to document clinical investigations, including expectations around supporting documentation related to clinical investigations, documenting other sources of data and considerations for documenting the overall assessment in relation to benefit/risk.

Date: 22 Février 2023

With the medical device regulations specifically stating that post-market clinical follow-up (PMCF) is a continuous process under the regulations, this webinar will focus on how best to document PMCF plans and evaluation reports.

Date: 8 Mars 2023

The summary of safety and clinical performance (SSCP) report is a new requirement under the MDR. This is one of the biggest areas where questions are raised by notified bodies as manufacturers attempt to produce a compliant document to the expectations of Article 32 and MDCG 2019-9. In this webinar, attendees will understand how best to produce a compliant SSCP for both healthcare professionals and patients.

Prior to his role at BSI, Richard worked as a clinical physiologist for 16 years within the National Health Service (NHS) specializing in implantable cardiac devices and electro physiology.

Richard joined BSI in 2018 bringing his clinical expertise and passion for clinical data to the organization. Richard is also involved with the working groups of the Medical Device Co-ordination Group (MDCG) for the EU.

Sheila Walsh holds an Honours Degree in Biomedical Engineering from the University of Ulster.

Sheila started her career in the Medical Device Industry focusing on the manufacture of Cardiovascular devices and Catheter based technologies. After this, she moved into a Clinical Research based role, where she was responsible for the conduct of Clinical Studies in the areas of Ultrasound Imaging and prediction of Stroke risk.

Sheila joined BSI in 2007 and has held various Technical and Clinical review and leadership roles. In her current position she is responsible for providing Clinical Regulatory support to the Operational Teams.

Rachel Mead holds an Honours degree in Electronics and Electrical Engineering from the University of Glasgow and is a member of the Institution of Engineering and Technology.

Rachel began her career almost twenty years ago as a research scientist in industry, where her focus was on magnetic biosensors. Since then, she has held research and development positions in medical device companies both at home and abroad. Her expertise includes technical and regulatory aspects, along with clinical investigations of medical devices.

Joining BSI as a Technical Specialist and Scheme Manager in 2018, Rachel currently holds the position of Technical Team Manager within the Active Devices Team, where she has a particular focus on clinical evaluation.

Jane joined BSI in February 2019 as a Technical Specialist, Clinical Evaluation Specialist and Scheme Manager within the General Devices team after working more than 20 years within the medical devices industry representing clinical affairs.

Prior to that Jane worked as a clinical investigator on a number of pre and post market clinical investigations and as a registered nurse within the NHS (UK). Recently Jane moved to the training team as Training Team Lead - Clinical working closely with the Clinical Compliance Group.

Nick, a Registered Nurse, joined BSI in 2020 as a Clinical Evaluations Specialist on the Active Implantable Medical Devices team. 

Prior to joining BSI, Nick worked in industry as a Clinical Support for a Ventricular Assist Device manufacturer covering the UK and Ireland. Nick also spent 7 years working as a Nurse in various NHS (UK) clinical settings including accident & emergency, cardiothoracics, interventional cardiology and latterly intensive care/transplant where he was a training lead, driving the development of local policies and procedures for the management of patients receiving mechanical circulatory support.