QMS for Medical Software: UK Market

Quality management systems (QMS) are a set of processes, procedures, and responsibilities that aim to ensure that products, including medical software, are safe, effective, and meet specific regulatory requirements. In the context of the QMS in the UK market, these requirements are particularly stringent for medical devices, including software.

A robust management system is key in minimizing the risks associated with every product lifecycle stage, from initial design and development through manufacturing, marketing, and post-market surveillance. For medical software, this is especially critical due to the potential impact on patient safety and the complexity of software development.

Introducing medical software to the UK market necessitates adherence to a comprehensive framework of regulatory and legal requirements. One of the most crucial aspects of this framework is the implementation of appropriate management systems, with a particular focus on establishing and maintaining a robust Quality Management System (QMS).

QMS in the UK is one of the most important management systems in the context of medical software. Its purpose is to ensure that software is designed, developed, and tested to the highest quality and safety standards. QMS implementation is required for any software that meets the definition of a medical device, regardless of its specificity.

Key Elements of QMS for Medical Software:

• Document management: Version control, archiving, and document structure.
• Risk assessment: Identify, analyse and minimise the risks associated with a product.
• Approval procedures: Define the processes for approving documents and changes.
• Decision Logs: Document decisions made and their justifications.
• Software validation: Ensuring that the software works as intended and meets certain requirements.
• Post-market surveillance: Monitoring the performance of post-market software and responding to any problems.

Furthermore, it facilitates risk assessment, establishes clear sign-off procedures, and maintains detailed decision records. Ultimately, your QMS is not merely a tool for compliance, but also a fundamental way of working. Consequently, it should evolve in line with company aspirations and throughout the lifecycle of the technology. If you are looking for more information on this topic. We recommend you read one of our latest posts: when software applications qualify as medical devices.

For medical devices, the QMS should comply with ISO 13485. This standard specifies the requirements for a quality management system that can be used by an organization to design and manufacture medical devices. Certification to ISO 13485 is often required by regulators and customers.

Medical software, as a medical device, is subject to safety and quality regulations. Consequently, medical software introduced to the UK market must meet the requirements of UKCA (UK Conformity Assessed) Marking. Furthermore, this compliance necessitates a robust QMS.

From 1 January 2021, all medical devices placed on the UK market (England, Wales and Scotland) must carry the UKCA marking. The CE marking is no longer recognised in the UK market. The process of obtaining the UKCA marking requires conformity assessment in accordance with UK regulations and cooperation with approved conformity assessment bodies based in the UK.

Non-UK producers are required to appoint a Responsible Person based in the UK. Their responsibilities include, among others, registering the product with the UK Medicines and Healthcare products Regulatory Agency (MHRA). They are also responsible for ensuring that the product meets all local regulatory requirements.

In addition to UK-specific requirements, medical software must also meet general requirements. These general requirements include the Medical Device Regulation (MDR) or the In Vitro Diagnostic Medical Devices Regulation (IVDR). The specific regulation depends on the product classification.

To sum up the implementation of QMS is a key element of the process of developing medical software for the UK market. It ensures that products are safe, effective and meet applicable legal requirements. For medical devices, the QMS should comply with ISO 13485 and be certified by an accredited body.

Source:

Regulations and guidance for developers. Planning for management systems, including a quality management system (QMS): https://www.digitalregulations.innovation.nhs.uk/regulations-and-guidance-for-developers/all-developers-guidance/planning-for-management-systems-including-a-quality-management-system-qms/