Increasing MDR and ISO requirements are no longer a challenge

Stricter MDR and ISO 13485 requirements call for structured collaboration

The medical device industry is one of the most regulated sectors, with continuously increasing requirements. As a result, quality management is no longer a one-person job. It requires more hands in the quality department and a structured approach embedded across the organisation – and in Heka Dental’s case, also beyond the organisation.

“We do not sell our products directly to the end user, but through dealers and distributors. That means our quality management requires a platform that everyone can access with assigned permissions – not only our own employees, but potentially also external technicians who sell our products to dentists”, explains Morten Gleie, Quality Manager at Heka Dental. He emphasises that it is a top priority that everyone always works with the most up-to-date documentation.

“Our platform is continuously updated to ensure that, as a company, we comply with our quality and documentation requirements. These are primarily ISO 13485, the standard for medical devices, and MDR, the Medical Device Regulation”, Morten Gleie explains.

A unified platform ensures correct training, documented quality, and full visibility of processes from A to Z

Internally, Heka Dental uses the D4InfoNet platform to document that each employee has the required competencies for the specific tasks they perform. “This is part of our regulatory work, and by using D4InfoNet for registration, it reduces my workload and provides better oversight for each individual”, explains Morten Gleie, who also uses the platform to record and communicate changes related to risk management, auditing, and supplier management.

There is one specific D4InfoNet tool that Morten Gleie finds particularly useful in his daily work, and which has been tailored specifically to Heka Dental’s needs: the Change Order tool. It structures the entire development process, capturing inputs, requirements, and specifications from one department to the next. This allows the quality department to monitor the process from A to Z.

“Our products are tested according to current requirements. And once they meet all the standards, we cannot simply continue development without performing a risk assessment. Here, we use D4InfoNet to get an overview of all workflows in the project at a high level”, Morten Gleie explains.

Tailored solutions create better structure, automation, and traceability

With automated workflows through D4InfoNet, Heka Dental has gained better oversight of all processes – from production changes to supplier management, training, and the development of new products that comply with ISO 13485 and meet MDR regulations.

“Together with D4’s consultants, we have continuously expanded the D4InfoNet platform. Partly to meet regulatory requirements, but also to make our daily work easier. It must not become too rigid, because then people skip steps or make changes without documenting them, and we lose traceability”, Morten Gleie explains.

Morten Gleie concludes by emphasising that it is also important for them that the system is Danish-developed. “D4InfoNet is easy for all employees to use. And it is an advantage that the support is Danish and close by. After all, time is money”, he adds.