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Lost in Translation – Finding a Clearer Path to Medical Devices Certification

September 2, 2020

From understanding standards to ensuring quality management systems are compliant, here are some common medical devices certification challenges.

Lost In Translation – Finding A Clearer Path To Medical Devices Certification
It’s not easy for medical devices manufacturers to introduce their devices to the market. A crucial part of the process is ensuring compliance with the various regulations governing medical devices. However, for that to happen, medical devices manufacturers must dive deep into current regulations, best practices, industry applications and the impacts they will surely have on their processes and product development. Not an easy task. Manufacturers must work to cover all bases, from understanding the relevant standards and ensuring you are compliant with the right ones to adapting processes and tools. The list of considerations is long, but we have tried to summarise them right here, just for you. So, without further ado, here are the most common challenges on the road to certification.



Identifying the right standards


The very first challenge is to identify which standards your device needs to comply with. This has the potential to differ depending on whether you want to sell it in the United States of America or in the European Union (EU). But in both cases, if you don’t obtain certification, your device will not be able to enter the market. If you are planning to commercialise your device in the EU, keep in mind that the new Medical Devices Regulation (MDR) will come into effect in 2021, introducing several changes to medical devices classes and therefore the requirements the devices must comply with. 

So, where do you start? There are always mandatory standards, common to most medical devices across all markets. For example, if your device includes software, you simply can’t escape IEC 62304 and IEC 60601. You can then determine whether your device is a high, medium or low risk class, giving you an idea of the standards you need to comply with. Another option is to find a partner that will help you not only to identify the right standards but also to understand them. This takes us forward to the next challenge.


Our experience…


It’s crucial to think ahead while developing projects as these will need to comply with whatever rules are in place once the project is finished. Otherwise, the final product won’t be certifiable. We’ve been helping medical devices manufacturers to prepare for the new MDR, from identifying gaps in their development and testing to adapting their processes to forthcoming changes. Check our white paper to learn how to prepare for key regulatory changes and their impact on medical device development.



Translating applicable standards to your reality


Standards can be overwhelming, not only because of their content, but also due to the technical language they use. This can result in misunderstandings or poor judgements pertaining to what they describe, which in turn can lead to the wrong choices being made. Not having a proper understanding of the standards means companies might end up following ones that are not applicable to them or to their work, thus making the devices uncertifiable.

It’s paramount that companies are aware of their own limitations. In this case, the best course of action could be to cooperate with an organisation that works in the field and is comfortable with the technical language required to comprehend the standards. This will provide the company with all the information they need, in an accessible and clear way, which will make the process of certification a lot more attainable.


Our experience...


Learn how we helped a medical image-processing company to certify their image correction systems as a Class IIb medical device, including supporting the certification of the device, preparing all necessary evidences, and assisting the company in producing all required artefacts demanded by European standards. Check out this case study for more information.



Adopting the ISO 13485 standard within your QMS


The ISO 13485 specifies requirements for a quality management system (QMS) where organisations must demonstrate their ability to provide medical devices and related services that are able to meet customer and applicable regulatory requirements consistently. This standard requires a significant investment and can have a great impact as it needs to either change or create from scratch risk assessment processes and goes as far as defining how data will be saved and who will be responsible for it. It’s mandatory for manufacturers to be ISO 13485-certified before the device is considered suitable for market.


Our experience…


We were approached by a multinational manufacturer of optical health devices to produce certification evidence for their quality management systems, including testing procedures compliant with FDA regulations. Check out this case study for more details.




Developing all the necessary and applicable documentation


Sometimes, reading and understanding the standards isn’t enough. To certify a device, you must ensure that it falls within a specific category and generate all the documentation applicable to said category. More often than not, you might realise that you’re missing a piece of mandatory documentation or that your processes aren’t compliant to the standards in question.
Beginning the development of medical devices without proper knowledge of the deliverables required by the standards will result in the costly re-working of processes. Thus, it’s important to do things right from the start.


Our experience…


We helped in the certification of medical device development processes according to ISO 9001:2008 and ISO 13485 for a state-of-the-art ophthalmology company focused on diabetic retinopathy. Working closely with the company’s in-house development team allowed us to bring together all the required evidence to demonstrate compliance with certification requirements. Check this case study for more details.



Developing software according to end-certification rules


Mandatory standards for medical devices using software include the IEC 62304 and IEC 60601, which, respectively, define the lifecycle requirements for medical devices software and pertain to the basic safety and essential performance of electrical medical equipment and systems.

Ensuring compliance with standards is a ride-or-die aspect of the medical devices industry. Each of these standards raises a different challenge. For example, the IEC 60601 is a quite extensive standard with several different sections. This can lead to misunderstandings about where a specific device would fit. The IEC 62304 standard raises specific needs in terms of the risk management and safety assessment of medical devices software. It demands significant changes to the development process, from traceability to testing, architecture design, verification and validation activities and more. 

Yet another extremely important standard to consider is the IEC 14971. This standard deals with processes relating to the management of risk, primarily to the patient, but also to other people, equipment and the environment. This standard is an ongoing process as manufacturers need to continuously update this documentation with production and post-production data.

Despite the crucial importance of complying with standards during the medical devices’ development, it’s equally important to consider the end-certification rules that might be relevant by the end of the project. For example, medical devices being developed right now, but that will only be completed next year, will have to abide by the new Medical Devices Regulation, due to be implemented in 2021. This new regulation will bring changes to existing rules and will also implement new rules that must be followed by companies and manufacturers. These new rules, despite only being applicable at the point when the device enters the market, must be considered and applied during development so as to avoid going back on processes to correct any mistakes.


Our experience…


Learn how we helped a global leader in medical technology who was developing a product whose software required specialist and independent certification. Our work identified several improvements in the product’s software coding early on, reducing the total cost of product development. The dynamism of the test procedures created meant the product could be fully certified within a short timeframe. Read this case study for more details.



The pressure is on for medical devices manufacturers. The consequences of failing to be compliant are not new – fines, lawsuits, loss of market access and market share and reputation damage. But the regulatory changes keep raising new challenges to manufacturers. The new Medical Devices Regulation is just one example. It will bring significant change in technical and clinical documentation, quality management system improvements, the implementation of Unique Device Identification, and post-market surveillance. Some of these will have a direct impact on software design and development processes, and manufacturers may need support to navigate the troubling waters of medical devices certification.

If you would like for one of our experts to help you as you make the journey towards certification, take a look at our medical devices page.

Want to learn more about our work?

Each of the documents below has been referenced in this article. Download them here to learn more about our experience in these different scenarios.