“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 operation 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 QA/RA Director at Innokas Medical.
The realization of all this in practice was audited at Innokas by the Notified Body and Certification Body SGS Finland during the past autumn. 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. The audits lasted unusually long this time and were particularly comprehensive due that Innokas wanted to take the new standard versions of the ISO standards in use already this autumn. As a result of these audit days, Innokas was granted with the newest versions of the certificates, and among the first Finnish companies, Innokas operates today according to the new certificates ISO 9001:2015 and ISO 13485:2016, as well as ISO 13485:2003 CMDCAS.
“The new, recently acquired versions of the ISO 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 ordinary engineering work or factory production. 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 describe 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”, Innokas Medical’s quality manager Katja Karhu, who works at Innokas’ quality department, describes the jungle of the rules and regulations.
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. Also the documentation needs to be done with high quality and proven traceability. This means the quality is built into the daily work and operation at Innokas – the rules and regulations defines how we operate, every day”, Kotipalo explains.
Innokas’ QA/RA team offers guidance and counseling – internally and externally
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.
Innokas QA/RA team also partners with companies in the field helping them to proceed with all quality and regulatory actions. Many medical device manufacturers find it difficult to allow sufficient time and resources to compile, maintain, and update a quality management system. However, it is impossible to operate without the QMS, so Innokas is also offering the quality system services. The demand of this kind of services is growing all the time, and customers have been very satisfied with Innokas’ services related to QMS.
“Innokas Medical guided our company in defining our ISO 13485 quality system, and trained our personnel and quality director. As a global player, Innokas is a great co-operation partner for our kind of start-up company also in the longer term”, Mikko Savola, who works as CEO at Monidor Ltd., gives an example.
The knowhow and experience related to regulatory requirements is also among the services Innokas has provided; Innokas offers its customers clear and concrete advices about quality and regulatory related issues, as well as help them to achieve regulatory approvals globally. For example, for VC150 Patient Monitor Innokas developed in cooperation with GE Healthcare, Innokas acquired CE mark for European market, the MDD license to Canadian market, the 510(k)-clearance for the device for the US market as well as the required market area specific radio device approvals. Innokas also tailors different kind of guidance and counseling sessions according to customer specific demand and situation.
“The cooperation with Innokas helps us to ensure that all the quality and regulatory requirements that the authorities have appointed to this sector, are taken into account. Innokas offered us, for example, very knowledgeable FDA-training, and as an outcome our personnel’s understanding of FDA requirements has grown and become more concrete”, explains Jyri Leskelä, who works as Quality Manager at Optomed.
The aim is to create an added value by Innokas QA/RA services for customer’s performance, and this seems to be achieved. Kotipalo and Karhu are very satisfied with the customer’s trust on Innokas strong position as a pioneer in medical device QA/RA issues in Scandinavia. Innokas’ continuous focus on development actions in QA/RA knowhow and expertise now bear fruits for Innokas. This fact is stated also by Manne Hannula, who works as Managing Director at Otometri Oy, who recently were one of Innokas QA/RA services customer.
“We have been very satisfied with the cooperation with Innokas’ experienced QA/RA team. Innokas’ strong experience and position as a pioneer in healthcare technology sector in Finland can be seen especially through the company’s willingness to develop and improve the whole healthcare technology sector and industry through its comprehensive experience and service offering”, Hannula concludes.
