This free-to-attend event is part of the West Midlands Academic Health Science Network (WMAHSN) industry event programme, aimed to support the West Midlands innovation ecosystem, and to make the West Midlands healthier, more productive and deliver the best possible clinical outcomes for patients.
Medical devices and IVDs are a highly regulated industry, and the regulatory considerations should be considered at the earliest stages of your strategic planning to help ensure that your products can be successfully approved and commercialised.
The webinar will provide a high level overview of the critical considerations and overview of the key steps needed from initial planning through to successfully selling the product after regulatory approval.
The webinar will cover the following focus areas;
- Regulatory planning as part of your product get-to-market strategy
- Considerations for product design and development
- Navigating the regulatory approval process
- Commercial launch and beyond – demonstrating continuing safety, performance and compliance to keep your product approval.
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Target audience
- This webinar training session is aimed at companies looking to or currently developing a new medical device and explores the critical strategic, operational and industry specific considerations necessary for successful commercialisation of a medical device or IVD product, with a focus on the regulatory and legal compliance environment.
- This webinar is aimed at business leaders, product developers, software developers, technical managers, quality and regulatory professionals.
Timothy Bubb, Technical Director, IMed Consultancy
Tim Bubb is a Principal Consultant and heads up the medical device consulting team at IMed Consultancy. Tim specialises in high-risk active therapeutic medical devices, software, digital health, and AI/ Machine learning, such as defibrillators, ventilators, and clinical decision support software. Tim has a wealth of experience in medical device quality, regulatory, clinical, and design engineering fields, having held senior industry positions in both multinational and SME manufacturers with overall responsibility for ensuring product legal compliance from concept through to regulatory approval, and successful commercialisation.
IMed Consultancy is a Medical Device and IVD specialist Regulatory and Quality consulting company, helping manufacturers achieve and maintain regulatory approvals for their products and quality management systems through a variety of consulting and representation services.