Responsibilities including InnoScot Health role as registered manufacturer.
Right Decision Service standard operating procedures
InnoScot Health takes the role of manufacturer (described below) for RDS tools categorised as medical devices. InnoScot Health will take responsibility for registering the decision support tool as a medical device, and for managing the relationship with the British Standards Institute (BSI) and any audit requirements for medical devices classified as Class 2a and above.
If your proposed decision support tool meets the criteria for a medical device, InnoScot Health will extend its current Technical and Quality Agreement with the RDS team and Tactuum to include any areas of activity your organisation will be responsible for. For example, you might take responsibility for defining business requirements, for the usability plan and usability testing, or for the clinical evaluation.
InnoScot Health and the Right Decision Service have entered into a strategic partnership through which InnoScot Health takes the role of manufacturer for any Right Decision Service tools categorised as medical devices.
Registered Manufacturer responsibilities
InnoScot Health acts as manufacturer who draws up a declaration of conformity with the requirements of the Medical Device Directive and applies UK CA marking to the medical device. .
InnoScot Health performs the Manufacturer’s responsibilities as set out in various Clauses of the relevant legislation governing Regulation – i.e. to:
- Have a system for risk management
- Have a system for quality management
- Conduct clinical evaluations
- Compile technical documentation
- Apply a conformity assessment procedure
- Be responsible for devices once they are on the market
- Have systems in place to cover their financial responsibility for harm caused by defective devices.
Clinical Safety Issues
As a Manufacturer, InnoScot Health holds, and will continue to hold, product liability insurance to the value of £5m. The design, manufacture, verification and validation of medical devices will be the responsibility of the designers, clinicians and other participating parties under the terms of their respective contracts with SHIL. The legally binding contract SHIL will put in place with third party contractors will determine the roles, responsibilities and actions that are required to minimise any clinical risk associated with the device. Through a formalised risk management process any risks will be mitigated as much as possible and any residual risks documented. SHIL will provide oversight and scrutiny of fulfilment of these requirements by 3rd party contractors, thereby ensuring the rigor of the approach.
Quality Management System
As an organisation, InnoScot Health is accredited by BSi to ISO 13485:2016, a quality management system designed to meet the requirements for safe and effective design of medical devices. Risk management is integral to this process. In managing the design process, SHIL will be part of a development team and will set out the framework for the development process. This will result in a project plan with documented risk management assessments throughout the project. All design and development processes will be performed in accordance with appropriate ISO standards.
InnoScot Health, the Right Decision Service and Tactuum (software supplier for the Right Decision Service) have entered into a Technical and Quality Agreement which sets out all of the responsibilities of each party, including complying with the requirements of ISO 13485.