The field of healthcare products, also commonly known as medical devices, is continually under development and all progress is being made exponentially in this sector.

Companies and start-ups that want to manufacture medical devices must meet very demanding design and development requirements to guarantee the safety and quality of products of this kind.

In general, companies are obliged to comply with EU Regulation 2017/745 on how a stringent quality management system must be applied throughout a product’s entire life cycle, i.e., from the design to manufacturing stages and also in the marketing and post-marketing stage.

The main goal here is to provide a legal framework for healthcare products to guarantee high levels of quality, safety and health protection and also foster innovations.

It is in this context that Tekniker, an organisation that is fully aware of the effort that companies and start-ups have to make with regard to developing products of this kind, has received an ISO 13485:2016 certification that will allow the technology centre to offer companies support to design and develop R&D&I projects for the healthcare industry.

It is, in fact, the first member organisation of the Basque Research and Technology Alliance (BRTA) that has received this certification which will reinforce its contribution towards the 2030 Science, Technology & Research Plan (PCTI) of the Basque Government, particularly in the strategic and priority area of customised healthcare.

Certification guarantees that Tekniker has a specific quality management system in place to develop the range of healthcare products covered by the regulations such as prostheses, orthoses, diagnostic devices or surgical materials, among many other items. Consequently, any companies or start-ups intending to develop healthcare products will not only be able to rely on Tekniker as a technological collaborator, but also receive all the support needed to meet all regulatory requirements efficaciously and efficiently to gain access to markets and speed up commercialisation actions safely, simultaneously meeting maximum quality standards.