Protacon was awarded a certificate according to the latest international ISO 13485:2016 standard for their quality management system for healthcare equipment, accessories and software. A management system will be required from all manufacturers in the healthcare technology sector within the transition periods defined by EU.
Building a quality system would not have been mandatory for Protacon who operates as a product development partner providing technology and software services; however, it remarkably facilitates cooperation with equipment manufacturers.
– Our customers have told us that it is not easy to find partners who master industry regulations. We wanted to meet this need and, for our part, take more responsibility for the safety of healthcare devices. Building a quality system was a relatively heavy process and took about a year to complete, but now we can offer really hard core experts for healthcare sector projects, says chief operating officer Juha Eloranta from Protacon.
A guarantee for sound business management
Previously, a quality management system was only mandatory for companies manufacturing equipment with a higher risk level. Within the transition periods defined in the regulations, a quality management system will be mandatory to all businesses operating in the healthcare sector regardless of the company size. Basically, the system must comply with the ISO 13485 standard.
– Today, the quality management standard rather defines the management system. The management system must be in good shape if you want to operate as a professional business, not as an amateur. I take my hat off to Protacon. They have done an excellent job with this achievement. An outsider will immediately perceive Protacon as a company to be reckoned with, and they have a head start in many ways. Companies manufacturing healthcare equipment greatly benefit from the fact that their partners apply the same quality system, says Tom Ståhlberg, Healthtech Finland’s director in regulatory affairs.
At the same time, you will build a positive image. Finding partners and investors is a lot easier when they believe that the company is credible, with sound management, of high quality, recognised and in good shape.
According to him, it is worthwhile building a modern management system complying with the standard in any company, already from the business point of view. It reduces all types of unnecessary hassle in the company.
– At the same time, you will build a positive image. Finding partners and investors is a lot easier when they believe that the company is credible, with sound management, of high quality, recognised and in good shape, Mr. Ståhlberg lists.
Healthtech Finland helps interpret standards
In addition, Protacon has recently joined the Healthtech Finland Association having also operated as a long-term member in the former network.
– We want to deepen our cooperation in the network to keep a finger on the pulse in the future as well. With our quality certificate, we want to help, for example, companies who themselves lack resources for auditing and validating their quality systems. In this way, we provide quality required by the CE mark starting from the early stage of the customer’s product development process, Mr. Eloranta says.
Healthtech Finland, former FiHTA, renewed its operating model in the autumn of 2016 and now works as part of Technology Industries of Finland.
– Our aim is to continue to reinforce growth and internationalisation of our member companies. Our members are interested in new technologies, such as artificial intelligence and robotics. We stimulate companies and present opportunities and contacts related to these, explains Healthtech Finland’s managing director Saara Hassinen.
The association does not grant quality certificates but offers expert help in regulatory matters for its members.
– Practical interpretation of the latest industry standards is not always easy for even authorities. We have the best experts in Finland and we work in close contact with regulatory authorities. In addition, we advance cooperation between the members and strive to solve bigger problems as well. However, we do not adopt any position on the social welfare and healthcare reform, since health technology companies offer solutions for both private and public operators. In addition to exports, the domestic market is important for health technology companies, and regulatory matters are a general requirement for entering the market. This is where we want to support companies, Ms. Hassinen says.
Chief Operating Officer
+358 50 541 3342