“At Innokas Medical, everything begins with the quality built into our processes, products and services. The most important know-how as well as the high standards of our daily operations can be seen through the high-quality daily work at Innokas – the quality is part of the work that is done, every day”, tells Tiina Kotipalo, who works as Head of QA&RA at Innokas Medical.   

The realization of all this in practice was audited at Innokas by the Notified Body, Certification Body SGS Finland and by many of Innokas’ customers during the past year. The audits were conducted to inspect how Innokas’ functions correspond to Finnish Law, EU Medical Device Directives and ISO Quality Management Standards including Canada requirements. Through the audits, Innokas has been granted with the new versions of different standards.

“Innokas quality management system is based on European Union Directives, US Quality System Regulation and Quality Management System standards. These regulations and standards set the guidelines for our processes, which need to be built in a way that they follow all the required directives and regulations. In other words – when our employees are following Innokas Medical procedures the requirements of the ISO 13485 and FDA QSR are fulfilled throughout the device whole lifecycle”, Kotipalo explains.

“During the year, there were altogether 56 audit days at Innokas. The new, recently acquired versions of the certain certificates indicate that Innokas quality management system is kept up to date all the time, and that Innokas operations are on a high-quality level. These certificates are essential for Innokas to be able to convince our customers and regulatory authorities that Innokas is capable to design and manufacture medical devices to the worldwide market”, Kotipalo says.

The jungle of rules and regulations

The design and manufacturing of medical devices is more challenging than design and development work or factory production for consumer devices as an example. Taking all the quality and official regulations into consideration is time-consuming - and requires considerable expertise. In addition to quality management systems, which every medical device manufacturer must have, the regulatory requirements concerning medical devices are very strict and complicated, both in Finland and in international markets.

“The EU’s medical device directive describes how we as a manufacturer of medical devices have to operate. In addition, our operation is regulated by Finnish legislation on healthcare equipment, as well as FDA regulations that apply to manufacturers who export their products to the American market. All the other country-specific laws need to be taken into account as well”, Kotipalo tells.

“Additionally, due to the new European Medical Device Regulations, MDR, there’s a lot you need to know as a medical device manufacturer. Thus, we’ve started to update our QMS according to new MDR requirements during the year. And in addition to MDR/IVDR, our QA&RA team has transferred to MDSAP (Medical Device Single Audit Program) -program, and some quality management system updates have been made related to this as well”, she continues.

In other words, it is not enough to have a good end-product. The development and production processes also have to fulfill certain criteria. The companies must also be able to verify that they operate according to these requirements.

“We have to be familiar with official regulations and we have to be able to implement them in practice. To ensure the safety and effectiveness of medical devices, the regulations have to be taken into account through the entire product life cycle. From the early product specification and component selection phase to sales approvals, production processes, supplier control and even after-sales services, it is mandatory to know and follow the regulations related to each phase. The documentation needs to be done with high quality and proven traceability also. This means the quality is built into the daily work and operation at Innokas – the rules and regulations define how we operate, every day”, Kotipalo explains.

Innokas’ QA&RA team offers guidance and counseling – internally and externally

There are altogether 4 persons working in Innokas’ quality and regulatory team today. In a world of constantly changing jungle of rules and regulations, Innokas’ QA&RA team receives additional training in quality management and regulatory affairs by participating to courses arranged by different Finnish and foreign training companies. Additionally, they have always been eager to learn new by self-learning from different sources. The new, updated QA/RA related information is also shared and trained to Innokas other employees regularly.

“By the training and consultation sessions that is kept in-house, the whole Innokas team works as a natural part of Innokas quality team to ensure that high quality and regulatory requirements are met throughout the device whole lifecycle”, Kotipalo ponders.

In addition to the official quality and regulatory team, the new center of excellence was launched and integrated into Innokas Design Studio few years ago: Design Controls. In practice, the function acts as quality and regulatory representative in Innokas’ design organization.

“Our Design Controls unit leads our design and risk management processes and keeps our engineering team up-to-date with changes in rules, regulations and standards in the field. It’s also supporting our customers and projects in terms of quality and regulatory and will participate in the official design reviews as QA&RA representative as well”, tells Jenni Tuulos, Head of Design Studio at Innokas Medical.

In future, Innokas’ Design Controls unit will offer external guidance and counseling more broadly, as Innokas has launched Design Controls as part of its Design Studio service offering. The demand of this kind of services is growing all the time, and customers have been very satisfied with Innokas’ Design Controls and other QA&RA related services.

“We have closed our first customer projects in Design Controls lately and will launch this service as official part of our Design Studio service offering”, Tuulos tells.

Quality and regulatory expertise as a competitive edge

Companies should clearly understand that in the medical field, the quality and regulatory compliance must be recognized and understood already at the idea phase. Thus, we see that the success in the future will be achieved through co-creation partnerships with professional cooperation partners, as recognizing and understanding the requirements throughout the whole device life cycle require strong expertise and know-how.

“Due to complexity and strict, but constantly evolving, regulations, the partnerships that emphasize co-creation over the entire product lifecycle will become more significant drivers for competitiveness. This is something Innokas’ organization highlights, too: in co-creation, all parties have a competitive edge and are able to add more value compared to the previous business models. When co-creating and manufacturing next generation medical devices with experienced partners, the added value can be very significant in terms of cost and time”, Kotipalo states.

The development and strengthening own expertise and know-how in quality and regulatory affairs is a clear strategic step towards a thought leader position in the field.

“The regulations are changing a lot in Europe at the moment. The amount of responsibilities for QA&RA Heads will increase due to e.g. new MDR/IVDR regulations in Europe. In the rest of the world there is a noticeable increase in regulatory requirements, too”, ponders Kotipalo.

“Due to this we’ve made a strategic choice to integrate QA&RA experts in our different business units. In addition to our comprehensive service offering from idea to design and development, to manufacturing and to after sales services, we will be able to even more comprehensively take care of quality and regulatory compliance in our different processes as well as during customer projects. The careful and professional QA&RA compliance and expertise may even become one of the competitive edges of companies in future”, she concludes.

For more information about Design Controls and the services related to this:

Pekka Pohjosaho, Head of Design Controls: pekka.pohjosaho@innokasmedical.fi

For more information about quality and regulatory affairs:

Tiina Kotipalo, Head of QA&RA: tiina.kotipalo@innokasmedical.fi