Nivalit Company is proud to announce that it has received ISO 13485:2016 certification for its quality management system on January 3rd 2023. This certification is specifically designed for the medical device industry and demonstrates our commitment to providing safe and effective products to our customers. The scope of certification covers: ‘Design and development, production, maintenance, service, and placing on the market of active medical device, including software for diagnostic and therapeutic purposes’.
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PN-EN ISO 13485:2016 is a globally recognized standard that sets out guidelines for quality management systems in the medical device industry. It covers all processes of company: from development and design to production, and servicing of medical devices. We have proven our ability to consistently produce safe and effective medical devices that meet industry and regulatory requirements.
Certification of quality management in medical devices industry
The certification process was done by an independent third-party CeCert auditor. The certification demonstrates our commitment to quality and patient safety and our ability to meet the stringent requirements of the medical device industry and regulatory bodies.
In conclusion, the ISO 13485:2016 certification is a significant achievement for Nivalit. It proves our commitment to providing safe and effective medical devices to our customers.