Evondos and ISO13485 – what does it mean for you

Commitment to Quality

Evondos has been in the market, with its Evondos E300 medicine dispensing robot and Telecare system since 2014, when we received the CE mark. Earlier this year we also introduced Evondos Anna medicine dispensing robot, with the new VideoMed functionality in order to support our clients even better.

Evondos is a manufacturer of Class I medical devices under EU MDR (Medical Device Regulation) and in June 2022 we received a certificate of conformity to ISO 13485, which is the Quality Management System standard for medical devices. This is a confirmation to our customers of our dedication to quality and compliance.

Not only is a certification a big step forward for us as a company, but it is also something our customers can benefit from. Let’s walk through it, what does this mean in practice?

QMS, MDR and ISO – what is the difference?

Quality, safety and compliance are the three key factors for a medical device manufacturer in all its actions. Plain and simple. This is brought even more to the forefront in the new EU Medical Device Regulation (MDR), which obligates the manufacturer to have and uphold a Quality Management System (QMS). Article 10 of the regulation requires that manufacturers establish, document, implement, maintain, keep up to date and continually improve a quality management system that conforms to the MDR standards. It also requires that the QMS is proportionate to the risk class and to the type of device. In other words, Class I poses a lower risk to the patient than Class III would do, and the QMS needs to provide enough tools to secure appropriate safety measures for the products and services in question

The medical device regulation also sets up a requirement for manufacturers to follow state-of-the-art methods. ISO 13485 is the gold standard Quality Management System for medical device manufacturers. The certification means that a 3rd party has audited our Quality Management System and its practical implementation, confirming the QMS follows ISO13485. This means two things 1) Evondos QMS meets the requirement of ISO13485, and 2) Evondos walks the talk: the procedures are being followed and there is documentation evidence to prove it.

lass I device manufacturers can place a CE mark on their devices once they have declared conformity to the regulations. There is no need for an authorized test laboratory (commonly referred to as notified body) involved in lower-risk class devices such as those in our segment. Customers undergoing tenders and purchasing devices or services must rely on each manufacturer's declaration of conformity.

Although a certification is not required for manufacturers under MDR, what would be a better way of establishing proven conformance to most of the requirements of Article 10 of the Regulation than having your quality management system audited by an external accredited, party?

How did Evondos QMS look like in the past

Our way of working has always been with our customers’ safety and security in mind. We were therefore not surprised when we looked back at our QMS. did a gap analysis against the Article 10 requirements. It was quickly noticed that the gap was not big. Evondos has had an advanced Quality Management System in use early on, although it was not developed strictly according to standards, nor certified by a 3rd party. However, we were already working in accordance with the QMS regarding risk control, documentation management, change management and post-market surveillance procedures But, there is always room for improvement. Prior to MDR European Union regulated medical devices by Medical Device Directive, which were generally not as tight and precise as today’s MDR.  Transforming our QMS from good enough for MDD to the state-of-the-art for MDR via ISO 13485 was not only something we saw that would benefit our internal processes and close gaps between functions.  Additionally, improved QMS gives our customers and partners additional trust in our way of working – and most of all is likely to improve patient safety even further. Why reinvent the wheel with a custom QMS when there are standardized and proven, methods?

What’s in it for you?

Our customers will also see a benefit from a standardized QMS, especially ISO 13485. Although medical device manufacturers have had to analyze the risks of their products within the Medical Device Directive (MDD), the Regulation (MDR) brought that aspect into an even larger focus. ISO 13485 is not any different. Risk-benefit calculations are at the heart of the standard and Quality Management Systems are certified against the standard. Customers can have peace of mind with devices designed, developed and manufactured within a certified ISO 13485 QMS because it is a proven, audited method of analyzing the risks for the devices and the processes of the manufacturer. No medical device is ever free from risk but understanding the risks and managing them with the industry’s best practice methods give the best tools to tackle and mitigate risks before they realize in actual incidents/cases.

When interviewing our customers, they often highlight quality as the most important attribute that they expect from their suppliers. However, it is challenging to define concrete requirements for quality during e.g., tenders. For customers, the tender process is already a big effort and going through Quality Management System definitions after another is cumbersome. A certificate is a fast, secure and uncomplicated way of showing that the correct methods are in use and this manufacturer can be trusted.

Certified manufacturers need to have safe and effective processes to ensure device deployment, including training and support.  Any feedback given is handled with standardized and proven methods because that is also covered and required by ISO 13485. Should customers need additional devices, they can rest assured knowing that the new devices are as safe and effective as any other device because manufacturing controls are in place throughout the manufacturing cycle.

Final thoughts

One of our core values at Evondos is “Passion for Improvement”. We live up to this value which is also the core ideal around ISO 13485: “Plan-Do-Check-Act”. From ISO 13485 we have gotten more tools and methods for continually measuring and improving our ways of working. Having internal and external audits in our yearly calendars directs us to do exactly what we promise ourselves to do; measure our performance and improve on findings. This gives tremendous value to each member of the company as well as all the stakeholders, internal and external.

Evondos Oy has an ISO13885 certificate that covers the design, development, manufacturing, service and sales of medicine dispensers. Subsidiaries are not yet certified but will follow the same procedures where applicable.

Sales Director Markus Mäkelä comments on the ISO certification: “We at Evondos welcome MDR and other collective initiatives to ensure the safety of medical devices. We consider it a positive development within the industry and it is definitely in line with our own and our customer’s interests. The higher the bar is in terms of safety and quality the less bad customer experiences there are when using the different solutions. We believe that it leads to a better reputation and increased demand for eHealth solutions collectively.” This summarizes well what we want to achieve in paying attention to quality at all levels.