Documenting those processes retrospectively may prove to be difficult or impossible. Although it can be a complex task, creating a plan and designing a QMS should, therefore, be your top priority.
In the end, your QMS, which has defined, tracked and logged every part of your design and development process, will also be the tool by which you draw out and compile your Medical Device File (also known as a Technical File, Design Dossier or STED file).
These are the documents that are essential to be audited by your Notified Body to secure your CE marking and finally get your product to market.
If you have been documenting all your processes as you’ve gone along it should be easier to do this.
The QMS, then, is critical to creating a smooth running, properly organised and documented design and build process that delivers a product that meets customer needs and is safe to use.
And it should do this by managing the risk of technical and commercial failure in a highly proactive way.
How a QMS helps you take a ‘risk-based approach’ to medical device design and development
By guarding against the risk of failure of the design and build processes, a QMS should ultimately help guard against customer harm or dissatisfaction, and, therefore, the commercial failure of the product itself.
What is Risk Management in Med Tech?
The purpose of risk management practices are to minimise the risk either to the achievement of the objectives of the med tech project or to the reliability of the developed device and safety of the users.
In any medical device development project a Risk Management Plan needs to be prepared. This plan lays out the approach to identifying, tracking and resolving each risk to a device, associated with its design, production, storage and usage.
The identification of hazards will also need to be documented in the Hazard Identification Document (HID).
All of these documents will ultimately be contained within the “Risk Management File”. And the elements of the plan should be implemented and evident according to the procedures of the QMS.
ISO 13485: 2016 and the risk-based approach
Risk is a hot topic in ISO 13485: 2016. It is mentioned much more frequently in the current documentation than in the standard’s previous iteration (10 times more often, to be exact).
ISO 13485 describes a developers’ responsibility in this area as an overarching risk prevention strategy. But it also acknowledges that this ‘risk-based thinking’ should be commensurate with the level of threat of harm posed by non-conformance in each area:
“The organisation shall apply a risk-based approach to the control of the appropriate processes needed for the Quality Management System”
Elsewhere the approach to risk is defined as:
“The systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk”
Helpfully, the regulation draws our attention to areas of particular importance here, including design and development, training and purchasing (i.e. working with third party suppliers).
These are areas where there is particular danger posed by non-conformance (e.g. a malfunction in design) or where there is increased risk of losing control over a particular area of compliance, for example in training or outsourcing.
The responsibility for assessing the compliance of your suppliers against the relevant regulations might seem an onerous one, but it is entirely consistent with the risk-based approach. And you will need to have a process in place to assess whether their QMS (and, therefore, any product or service they are supplying to you) is compliant.
But this risk-based approach, with its focus on outcomes and reducing risk of customer harm or dissatisfaction can also be an opportunity.
It is intended, after all, to move away from an ‘inspect and control’ regulatory paradigm for the improvement of quality in the medical device industry and save companies the effort of endless remedial work.
It should mean you are continually reviewing processes and focused on improving the consistency and quality of your end product before anything goes wrong. This is an opportunity for innovation as you strive to make your processes as efficient, innovative and error free as possible:
5 benefits of adopting the Risk-based approach to quality management in ISO 13485:2016
- Improved levels of regulatory compliance
- Process efficiency improves when attention is placed on higher risk issues and requirements and dialled down for lower risk items
- Enables companies to focus efforts on the aspects of the QMS with the highest risk
- Ensures problems are solved before they impact the product – reduces costs of remedial work
- Innovation through the effort of continual improvement
Risk management as part of medical device design requirements
One of the harmonized standards associated with ISO 13485 is ISO 14971 – “Application of Risk Management to Medical Devices”
Those requirements are clearly stipulated within ISO 13485 itself.
Clause 7.1 of ISO 13485: 2016 specifies the way the risk management requirements of the QMS should be implemented as you begin to formally design and build.
It describes a mandatory process for planning and product realisation, which governs, captures and records every material stage of the design and development of a medical device. These processes are put in place to minimise the risk of failure, while promoting transparency and accountability at all times. And you need to plan for this.
ISO 13485 expects you to create a medical device design process that:
- Breaks the process down into stages and with identifiable deliverables at each stage
- Identifies check points for reviews and specifies its participants
- Establishes a communication plan and a mechanism for communications
- Creates and updates necessary records as the process continues
As part of the way risk is managed throughout the process the QMS must also make provision for proper design change control; devising processes that assess the potential risks involved in making alterations. To this end ISO requires that you:
- Document the design changes
- Approve the changes only after review and verification
- Evaluate the effects of changes
- Document the results, and take any necessary corrective and preventive actions to solve problems arising from them
It will take time and effort to ensure you get all this right. It will take considerable time and effort to create and define the SOPs that form your QMS as a whole, as well as building the system of digital or real world files where all its outputs will reside.
It will be expensive, time-consuming, and even impossible to piece all that together retrospectively.
But the reality is you will not be able to deliver or legally market your product without doing this.