This 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.
The following course has been devised and presented by AcclaimBiomedical Consulting, Medilink Midlands and the WMAHSN to offer a rich and rewarding training experience.
- Software is playing an increasingly important role in the medtech sector, we see developments in smart devices, embedded software and wearable healthcare technology. We also see that European Regulations are developing to address this technology with increased scrutiny and specific requirements for these products .
- This webinar training session is aimed at all companies developing and maintaining these types of products and explores the pathway to compliance .
The top 10 tips
The course will cover the following focus areas
- Planning is Critical
- Understand thoroughly the intended use, user and use environment
- Risk Classify your product
- Consider local requirements (GSPR)
- Follow a documented process for product development IEC62304
- Appropriate selection of development environment
- Consider user interface (Usability)
- How will this be maintained
- Connections
- Cyber security
Learning Objectives
- Working with quality and regulatory teams including demonstration of design process control:
- Study the application of recognised standards and good practice as well as documentation expectations.
- Explore the need for risk management and human factors engineering in this product sector.
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Speaker Profile:
Richard Young, Managing Director, AcclaimBiomedical Consulting Ltd
Richard has an extensive background in regulatory affairs in addition to GMP (quality assurance), GLP (laboratory testing), and GCP (clinical). Spanning over two decades, these core skill areas have been developed with experience in products ranging from class 3 devices such as Orthopaedic implants (IIb) neurological robots, through electromedical devices such as infusion systems and cardiovascular products.
Richard brings a blend of pragmatism and experience to these disciplines that facilitate insightful problem-solving approaches as well as solid solutions.
Richard’s skills and experience includes such areas as the development and implementation of effective quality management systems, auditing to ISO and FDA QSIT standards, and operating at national and international level through industry associations including Eucomed, ABHI, and ABHI Technical Policy Group.