Free webinar encourages medical device pioneers to explore ‘anatomy of a Quality Management System’
A free webinar will be sharing insights on the best routes to quality management, ensuring the safe and effective design of medical devices
On Wednesday 29 April, InnoScot Health — a key partner in realising healthcare innovation ambitions for Scotland — will be inviting medical device innovators and manufacturers to learn more about the key components of a Quality Management System (QMS) and how they work in practice.
This structured framework of procedures and processes is designed to ensure product safety, quality, and regulatory compliance throughout the entire lifecycle of medical devices.
InnoScot Health operates an accredited ISO 13485:2016 QMS — the internationally recognised standard — to support forward-thinkers across NHS, industry, and academia in developing, regulating, and commercialising new health technologies.
The lunch and learn session, entitled ‘Anatomy of a Quality Management System – supporting continuous improvement in the delivery of medical devices’, takes place from 12-12.45pm and will be presented by InnoScot Health’s Quality Manager Lauren Brophy.
A highly experienced addition to InnoScot Health's regulatory team in 2024, Lauren is an expert in Quality Management.
Prior to joining InnoScot Health, she worked for six years in the medical device industry as a Quality, Regulatory and Training Coordinator with an Edinburgh-based medical technology company.
During that period, she worked closely with distributors around the world, registering medical devices in countries including Thailand, India and Taiwan while becoming adept at conducting comprehensive training.
Lauren further developed substantial know-how in implementing ISO 13485:2016 and in the compilation and review of technical documentation for UKCA/CE marking.
She is also an ISO 13485 certified auditor with InnoScot Health partners such as MR CoilTech continuing to reap the benefits of that deep expertise which maintains high standards, reinforces positive reputations, and supports improved efficiency.
Lauren said: “Understanding QMS requirements for rigorous regulatory controls is a huge asset so I believe this will be a very useful session for medical device pioneers, offering unique insights with tailored advice based on significant experience.
“It’s about not only understanding and meeting the key requirements of a QMS but also maintaining them to the correct standard so that you remain compliant.
“This webinar is for anyone dedicated to improvement in health and care who wants to better understand Quality Management Systems and their potential to enhance ambitions.”
InnoScot Health offers a skilled team of regulatory experts. Consultancy, training and advice is available to ensure awareness and compliance with legal responsibilities while supporting the design and development of products under an accredited regulatory framework.
Complying with medical device regulation
InnoScot Health offers a skilled team of regulatory experts. The organisation also operates an ISO 13485:2016 quality management system harmonised to the Medical Device Directive.
Consultancy, training and advice is available to all NHS health boards, plus companies or universities working in partnership with NHS Scotland to develop medical devices. We ensure awareness and compliance with legal responsibilities and support the design and development of products under an accredited regulatory framework.
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