The three-day recertification audit, conducted by Eurofins Electric & Electronics Finland Oy, thoroughly reviewed Solita’s entire quality management system. Auditors examined processes, evaluated project evidence, and verified ways of working with quality management records. The outcome was the best possible result: the certification has been renewed for the next three years.
“Achieving the recertification confirms that our processes and services meet the highest international quality standards for medical device development,” commented Risto Kaikkonen, Director of the Solita Health unit. “This enables us to continue supporting the most impactful healthcare projects and ensures that the solutions we help our customers build are safe, effective and sustainable.”
Ensuring long-term impact in healthcare
ISO 13485:2016 certification is essential for any company working in the medical device industry in order to provide services to medical device manufacturers. Together with the Solita’s RegProof® service model, the certification strengthens Solita’s ability to deliver long-lasting impact in healthcare, ensuring safety and compliance in digital health and smart medical device solutions.
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For more information
Solita, Risto Kaikkonen, Director, Solita Health and Wellbeing Division, +358 41 536 8745, [email protected]
Solita, Sari Kaari, Quality Manager, +358 40 046 4520, [email protected]
About ISO 13485:2016
ISO 13485:2016 is the internationally recognised standard for quality management systems in the design and manufacture of medical devices. Certification demonstrates an organisation’s ability to provide medical devices and related services that consistently meet customer and regulatory requirements.