Do you have a Medical Device or In Vitro Diagnostic (IVD) that you are in the process of developing and would like to bring to the market? Are you feeling lost in the world of quality and regulatory, and unsure about what steps to take during the design and development stages? Well, you’re not alone…In this blog, we touch on the processes you should follow and the documentation you need to create, to bring your device to the market.
Firstly, you need to understand that ISO 13485:2016 is an industry standard for medical device Quality Management Systems (QMS) and one that is adopted by a vast number of medical device companies. It is the internationally recognised benchmark that ensures medical devices meet proper regulatory compliance requirements, as well as customer needs.
The QMS incorporates procedures, work instructions, controlled forms and templates that describe how to lock down and control all activities related to your business and medical device(s) and the key to any successful medical device, is ensuring the correct processes are implemented and followed as early as possible in the design phase.
Two very important procedures to consider and implement early on when developing your device are:
- Design and Development – You should have a robust design process in place that covers, but is not limited to, the requirements listed under clause 7.3 – design and development of ISO 13485, including any applicable regulatory requirements.
- Risk Management – Your risk process should be implemented early on and align with the requirements of ISO 14971:2019 – Medical devices. Application of risk management to medical devices & ISO/TR 24971 – Medical devices. Guidance on the application of ISO 14971.
What Are the Stages of The Design and Development Process?
Later in this blog, we expand on the required design stages described in ISO 13485:2016 and the information that should be documented when you design and develop your device.
The Design Process in Figure 1 is a typical overview of the logical approach to apply to the phases of the design and development operation. In simple terms, the device requirements are developed and made to those requirements. It is then followed by verification and/or validation through to production and then manufacture.
Figure 1: Design Process Overview
Design Reviews
Design reviews, also known as ‘stage-gate meetings’, are generally used to provide assurance that the activity or design phase has been satisfactorily completed and that the next stage of design can begin. They should be held at documented intervals throughout the design process, and the minutes recorded e.g., a review is conducted to ensure that design inputs are adequate and applicable to the device before work is carried out to convert them into design outputs.
Stage 1: 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 the information listed below. Note, this is not an exhaustive list:
- The project objectives and scope – e.g., what is to be developed,
- Design and development stages – inputs, outputs, verification & validation, design transfer, product launch,
- Actions and deliverables – responsibilities of the team to ensure quality during the design and development of the device,
- Intended markets for product launch,
- An identification of QMS documents, procedures and resulting records applicable to controls for design and development,
- Organising design and development reviews, including the selection of reviewers, the composition of review teams, and procedures to be followed by reviewers appropriate to each task or stage/phase,
- Risk management activities,
- Selection of suppliers.
By having a plan in place, you can control the design and development process and be accountable to agreed timeframes.
Stage 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 whilst designing your device.
The design inputs should be based upon the defined intended use. These should include but is not limited to:
- User needs and expectations
- User requirements specification
- Product requirements (considering any available product-specific standards)
- 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 to enter those markets
- Safety requirements
- Performance
- Usability
Stage 3: Design Outputs
The design outputs should be documented within a Design Traceability Matrix, and relevant documentation should be created, such as the following, but is not limited to:
- Product specifications (requirements and characteristics),
- Specifications for raw materials, component parts and sub-assemblies and medical devices,
- Packaging and labelling specifications,
- Design drawings and schematics, including manufacturing and assembly instructions,
- Product and process software,
- Manufacturing and inspection procedures,
- Documentation for submission to the regulatory authorities where the medical device will be marketed, if appropriate,
- Records to demonstrate that the design and development process was carried out in accordance with the design and development plan,
- 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., the risk analysis, and report.
Figure 2: Risk Management Process Overview
Stage 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. Figure 3 documents what is meant by design verification and validation:
Figure 3: Design Verification vs Design Validation
Verification and validation documentation can include, but is not limited to the following:
- Testing and analysis (Verification/Validation methods and acceptance criteria),
- Prototyping,
- Clinical Evaluation Documentation,
- Performance Evaluation Documentation,
- Clinical trials (where applicable).
Stage 5: Design Transfer
Design transfer is the process of transitioning a medical device design from the design and development stage into manufacturing.
On completion and approval of all verification and validation activities, you can move on to the design transfer stage. The design transfer should be documented in the design and development tracker and meeting minutes. At this stage, design transfer documentation, such as production records, must be created and passed onto manufacturing for the purpose of releasing the device to market.
Stage 6: Control of Design Changes
If any changes are required to your device at any stage during the design and development process, they must be documented in accordance with your change control process and reviewed to confirm whether the changes are classed as ‘significant’ in line with any regional regulatory requirements e.g. EU MDR 2017/745. You will also need to demonstrate that you have reviewed, verified, and validated the change prior to implementation.
Stage 7: Design and Development File
A design history file (DHF) is the organised documentation of all product design and development processes pertaining to your finished medical device. It must be maintained for each medical device product family and contain the documentation created during the design stages, as explained in this blog.
This file can include, but is not limited to:
- Results of engineering, laboratory, simulated use, animal tests and evaluation of published literature applicable to the medical device or substantially similar medical devices regarding the safety of the medical device and its conformity with its specifications,
- Detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test results and conclusions regarding,
- Biocompatibility (identifying all materials in direct or indirect contact with the patient or user),
- Physical, chemical, and microbiological characteristics,
Electrical safety and electromagnetic compatibility,
- Stability/shelf life,
- The report on the clinical evaluation,
- Post-market clinical follow-up plan and post-market clinical follow-up evaluation report,
- Regulatory strategy and submission documentation.
Get Your Free Design Traceability Matrix
Compiled by the experts at LFH Regulatory, this Design Traceability Matrix template will provide a clear roadmap for documenting your customer requirements, design input/outputs including design verification & validation activities during the development of your device.
Click here to send a request and we’ll email you a copy of the Design Traceability.
Still unsure what to do? LFH Regulatory can help…
LFH Regulatory have a team of experts who can assist you with making sure you have the appropriate design documentation in place. Contact us today on +441484662575 or via info@lfhregulatory.co.uk. Alternatively, you can also click on the ‘Contact Us’ button below to see how we can help.
References
- EN ISO 13485:2016+A11:2021 Medical devices – Quality management systems – Requirements for regulatory purposes.
- ISO 13485:2016 Medical devices. Advice from ISO/TC 210. A Practical Guide.
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.
- ISO 14971:2019 Medical devices – Application of risk management to medical devices.
- ISO/TR 24971:2020 Medical devices – Guidance on the application of ISO 14971.
