Quality in every area – Sii supports the manufacturing process of medical devices with the ISO 13485 certificate

Quality and safety play an extremely important role in the manufacturing process of medical devices. Sii, meeting the requirements of one of the key certificates for this sector – ISO 13485: 2016 – can ensure that all projects implemented for this industry comply with the strict requirements. Sii customers can count on a guaranteed level of compliance with specialized guidelines, which, among others, will facilitate the process of validation and control of a ready product.

For many, the ISO 13485 standard is associated only with the production of specific medical equipment or pharmacological products.

– Quality Management for medical devices is also dedicated to the supply chain and organizations supporting the production of medical devices from many sectors, including those providing technological services: software or statistical models helping in, for example, the selection of the target group of patients – explains Piotr Mazurski, Senior Security Specialist at Sii.

Comprehensive services for the medical industry

Thanks to the development of competencies and experience, Sii can not only provide services for the medical industry but also support clients from this sector in obtaining compliance with ISO standards, including ISO 13485: 2016. It is often necessary to meet certain requirements for contractors and market regulators.

– At Sii, we specialize in providing solutions that support quality, but also safety, so we comprehensively approach the preparation and implementation process, paying attention to aspects that are often marginalized – says Sebastian Pyzik, Compliance Security Department Manager at Sii.

Support in preparation for the audit

Sii is an organization with well-structured processes and repeatedly audited (ISO 27001, TISAX, or the extremely restrictive Common Criteria EAL6). Therefore, it can help its clients prepare for the official audit by identifying the areas that need special attention and sharing good practices necessary to successfully pass the process.

– Due to companies’ need to adapt to the changing IVDR regulations, we currently have a large number of inquiries in this area, including requests for preparing documentation related to medical standards or documentation audits. We are glad that we can better support existing and new customers in their challenges – says Wojciech Drescher, Head of the Healthcare Industry at Sii.