Join Medilink as we host a Regulatory event as part of WMHTIA, created in collaboration with Regulatory experts JensonR+.
Sessions will focus on the following topics:
- Design for Compliance: Early approaches to regulatory compliance in the design phase.
- UK Regulatory Roadmap for Medical Devices – Looking to cover both hardware and software based medical devices.
- Access to Medical Device Markets: Access to Medical Device Markets: UK, EU, Switzerland, US and China offers significant strategic and growth potential.
Speaker Information
Tom Wood, Regulatory Manager, Medical Devices, JensonR+
Tom has many years of experience in both medical device companies and in notified bodies as an auditor and technical expert. He has worked in both CE and UKCA marking alongside ISO 13485, ISO 9001 and MDSAP. Tom joined JensonR+ Ltd in May 2023 to lead their medical device services. Since joining JensonR+ he has worked with many of our clients both new and existing in developing their quality management systems, preparing regulatory submissions and supporting drug device combination products for our pharma clients.
Victoria Caldy, Business Development and Marketing Director, Cisema
Victoria has over 25 years’ experience in diverse health-related companies including helping to build a class III medical device company from the bottom up which included navigating international regulatory approvals. More recently, Victoria has been advising Life Sciences, Cosmetics and Health Food companies worldwide, from start-ups to MNCs, on the best regulatory pathways to market in China and how to maintain compliance in such a complex market.
To read more about Medilink Midlands’ role within the WMHTIA project, click here.
For more information on the wider project, click here to visit the WMHTIA website.
This event forms part of the West Midlands Health Tech Innovation Accelerator (WMHTIA) event series. Medilink Midlands are one of a consortium of delivery partners for the WMHTIA, a project funded by the Department for Science, Innovation and Technology, Innovate UK and West Midlands Combined Authority (part of City Regions).