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SHIL awarded Quality Management System accreditation image

Scottish Health Innovations Ltd (SHIL) has achieved ISO 13485:2016 Quality Management accreditation for medical devices.

This internationally recognised standard demonstrates compliance to stringent medical device quality standards, and enables SHIL to provide a regulatory framework to support the design, development, production and delivery of medical devices.

Medical devices are crucial in diagnosing, preventing, monitoring and treating illness, and overcoming disabilities. They play a key role in delivering new products that benefit the NHS, economy and, above all, patients.

Of significance, NHS health boards across Scotland are not only involved in the procurement and use of medical devices; but also produce and manufacture medical devices. SHIL offers consultancy and advice to ensure awareness and compliance with evolving and increasingly stringent legal responsibilities, and to support the design and development of products under an accredited regulatory framework.

Elaine Gemmell, Head of Strategic Development at SHIL, who has more than 15 years’ experience in medical device development, and led the team through the accreditation process, comments:

“Medical device regulation is a specialist area and it is vital NHS Scotland, in addition to academia and industry, have access to high-quality advice and support. Our decision to attain ISO 13485 accreditation, recognises our commitment to improve continually our quality management system and demonstrates that SHIL meets the strict regulations and demanding requirements of the medical device industry.

“This accreditation enables SHIL to provide a regulatory framework to design medical devices and manage the process from initial evaluation of a concept to regulatory approval and launch to market. It also coincides with significant and more onerous changes in the medical device regulatory landscape; and so SHIL is well placed to support NHS Scotland, and partners, navigate these important changes.”

Graham Watson, Executive Chairman at SHIL, comments:

“Achieving ISO 13485 accreditation is testament to the talent and professionalism of the SHIL team. With a long record of protecting the interests of NHS Scotland, achieving this internationally recognised standard reinforces our commitment to quality and process excellence; and ensures the SHIL team continue to provide high-quality, reliable advice and expertise to accelerate innovation across NHS Scotland."

The regulatory advice service offered by SHIL, and underpinned by this accreditation, is part of a suite of expert services offered by SHIL including intellectual property advice, funding, product development and commercialisation – each designed to accelerate the translation of innovative ideas into viable products and services to improve patient care and generate a financial return to NHS Scotland.

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  • New medical device regulations reflect substantial technological and scientific progress in this sector over the last 20 years. Two new European regulations (Medical Devices Regulation (MDR) EU 2017/745 and In-vitro Diagnostic Medical Devices Regulation (IVDR) EU 2017/746) are replacing three existing directives (Directive 90/385/EEC Active Implantable Medical Devices (AIMD), Directive 93/42/EEC Medical Devices (MDD), and Directive 98/79/EC In-Vitro Diagnostics (IVD)) in the years up to 2022.
  • The new regulations are more stringent than the directives they replace, have an impact on everyone involved with medical devices, from their manufacture to their use. The ongoing coronavirus pandemic also has implications for the regulatory environment.
  • Adopting ISO 13485:2016 provides a practical foundation to address the Medical Device Directives, Regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices. ISO 13485:2016 was written to support medical device manufacturers in designing quality management systems that establish and maintain the effectiveness of their processes. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
  • SHIL engaged BSi – a UK notified body to audit the organisation. The two-stage process started in October 2019 and included an internal audit programme, management review and staff training to ensure conformance.  

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