Spyrosoft is now certified with ISO 13485, QMS standard for medical device development

Matylda Chmielewska

Content Specialist

After months of preparations and a thorough audit from the TÜV NORD, we can now proudly announce that Spyrosoft has been granted the ISO 13485 certification which is crucial for ensuring the quality of the medical device development. 

What does it mean? We’re even more well-equipped to develop outstanding medical devices (software as well as hardware) for our clients. The ISO 13485 standard is globally recognised as the essential norm that specifies how a quality management should look like where a company is required to show its capabilities in developing medical devices and related services. As stated on the International Organization for Standardization website, this standard is applicable for firms ‘involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g., technical support)’. 

At Spyrosoft, we’ve been filling the role of technological partner for multiple companies from the healthcare sector, so we have hands-on experience with building software (also Software as a Medical Device) that complies with ISO 13485. Now, we have official confirmation of our abilities in this area. Our Head of Quality, Marek Pałka sums it up: 

‘The certification of our Quality Management System completes over a year-long journey of ISO 13485, ISO 14971 and IEC 62304 standards implementation. It also awards our efforts in making our QMS specifically designed to support not only software development part of a medical device, but all its stages of product lifecycle. This is especially crucial for us as a service delivery provider – to be able and to be flexible enough to provide support from the early idea of a medical device definition through its certification and registration process as well as maintenance once the product is on the market.’ 

How will this certification influence the growth of our Healthcare and Life Sciences Business Unit? Its Director, Krzysztof Minicki explains it in more detail: 

‘The certificate confirms our abilities as a professional supplier of healthcare solutions. It guarantees that the products we build are developed in compliance with the required standards, norms and regulations. Our clients get the necessary technical documentation that has been prepared in alignment with our certified Quality Management System. All of our processes comply not only with the ISO 13485 but also with IEC 62304 and ISO 14971. This also means that for our customers, releasing new products onto the market and getting them classified in accordance with the Medical Device Regulation is easier than ever. We are a reliable technological and business partner.’ 

We’re always looking for opportunities to expand our knowledge and skills, so stay tuned for our next announcement!