MTI
A new appointment for formal NHS Scotland partner InnoScot Health is expected to further boost its regulatory expertise in medical device development, from initial selection through to commercialisation according to the company.
Representing an experienced addition to the team, Quality Manager Lauren Brophy will work closely with Head of Regulatory Affairs, Elaine Gemmell, to help accelerate the development of innovative products and technologies with NHS innovators, partners and clients.
She will be responsible for the maintenance of InnoScot Health’s Quality Management System (QMS) whilst also supporting its quality and regulatory activities after having worked closing with distributors around the world, registering medical devices in countries including Thailand, India and Taiwan.
Gemmell said: “With six years’ experience in the medical device industry, successfully managing Quality Management systems and ensuring all is maintained and controlled, Lauren is a valuable addition to our regulatory team.
“With her strong track record of working closely with suppliers on approvals, we expect she will also play a leading role in achieving InnoScot Health’s overarching aim of identifying, protecting, developing and commercialising healthcare innovations to improve patient care.
“Part of her remit will be engaging with health and social care staff across NHS Scotland, SMEs and universities to provide strategic advice and assist in the implementation and maintenance of ISO 13485 QMS, the harmonised standard across the medical device industry. This is an important part of our work and an area in which Lauren is a certified auditor.
“She will further provide training, offer regular communication with clients to provide important updates on regulatory changes that could affect their businesses, and conduct awareness activities around what we can offer.”
Brophy was previously with an Edinburgh-based medical technology company for six years in the position of Quality, Regulatory & Training Coordinator.
There, she developed substantial experience of implementing ISO 13485:2016 – the medical industry's optimal medical device standard which ensures that all medical devices meet the proper regulatory compliance laws and customer needs – and in the compilation and review of technical documentation for UKCA/CE marking.
Gemmell added: “We are delighted to welcome Lauren and are certain she will flourish in her new role thanks to proven credentials in regulatory affairs that will take our offering to the next level.
“I believe she will be instrumental in expanding our regulatory services and providing high-quality advice and support is available to innovators across Scotland as they navigate often complex regulatory frameworks to ensure the supply of safe, effective and innovative medical products.”
Brophy said: “I’m excited to have this opportunity of lending my knowledge to InnoScot Health’s already comprehensive offering in providing quality/regulatory services to the NHS, industry, and academia, in turn encouraging fresh ideas and collaborations.
“I believe my 20 years of experience in customer service and 14 years of project management and honing organisational skills within a corporate environment can be useful in that regard.
“Ensuring the presence of an appropriate regulatory framework for the development of products or technologies disclosed to InnoScot Health is vital to success, and it’s an area I hope to work with the organisation on further strengthening.”
