Regulation
nature of design and development. To enter the UK market and access the NHS, there will be a requirement to demonstrate compliance with ISO 13485 and, hence, it is important to have a robust design control in place for your medical device.
Key medical device design stages 1. Design and Development Planning - A Design and Development Plan is essential: it is there for you to understand the scope of the product development requirements. When documenting the plan, you need to consider information such as:
l The project objectives and scope – e.g., what is to be developed.
l Design and development stages – the inputs, outputs, verification and validation, design transfer, and product launch.
l Actions and deliverables – responsibilities of the team to ensure quality.
l Intended markets for product launch. l An identification of QMS documents, procedures and resulting records, applicable to controls for design and development.
l Organising design and development reviews, including the selection of reviewers.
l Risk management activities. l Selection of suppliers.
By having a plan in place, you can control the design and development process and be accountable to agreed timeframes.
2. Design inputs - Design inputs are classified as
‘the physical and performance requirements of a device’ and will take into consideration customer needs – these should be used as a basis, while designing your device. The design inputs should be based upon the defined intended use. These should include:
l User needs and expectations. l User requirements specification. l Product requirements (considering any available product-specific standards).
l Regulatory requirements – which markets are you looking to sell your device into, and do these have any specific requirements you need to take into consideration?
l Safety requirements. l Performance. l Usability. 3. Design outputs - The design outputs should be documented within a Design Traceability Matrix, and relevant documentation should be created, such as the following:
l Product specifications (requirements and characteristics).
l Specifications for raw materials, component parts and sub-assemblies and medical devices.
l Packaging and labelling specifications. l Design drawings and schematics, including manufacturing and assembly instructions.
l Product and process software. l Manufacturing and inspection procedures. l Documentation for submission to the regulatory authorities where the medical device will be marketed, if appropriate.
l Records to demonstrate that the design and development process was carried out in
accordance with the design and development plan.
l Risk management documentation in line with ISO 14971, including the device characteristics checklist (according to Annex A of ISO/TR 24971, and for IVDs, consider Annex H as well as the risk analysis and report.
4. Verification and validation - Verification and validation activities should take place to ensure that the device meets the defined input requirements and specifications. While verification and validation are both elements of the medical device testing process, they serve two very different but equally essential functions. l Verification - During device verification, you verify that your design outputs meet your design inputs. In other words, did you design the device right?
l Validation - During design validation, you prove that the device’s design meets the user’s needs and intended users you’ve specified. In other words, did you design the right device?
Verification and validation documentation can include, but is not limited to the following: l Testing and analysis (Verification/Validation methods and acceptance criteria).
l Prototyping. l Clinical Evaluation Documentation. l Performance Evaluation Documentation. l Clinical trials (where applicable).
It is important to remember, should the
Figure 2 – MHRA Roadmap towards the future regulatory framework for medical devices (2024 – 2025) 34
www.clinicalservicesjournal.com I June 2024
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