Prometheus DeltaTech achieves ISO 13485 Certification

Achievement of ISO 13485 certification constitutes an important milestone for the company and the Prometheus Medical Group

Prometheus DeltaTech, an innovator and developer of medical technology solutions for the emergency medicine and medical markets, has been granted the international ISO 13485 certification from the National Standards Agency of Ireland (NSAI).

The ISO 13485 Standard specifies the requirements for a quality management system where an organisation must demonstrate its ability to provide medical devices that consistently meet customer needs and regulatory requirements applicable to medical devices.

The achievement of this important objective is a key step towards delivering new products to the European, North American and other global markets over the course of the coming years.  This certification also serves to demonstrate the company’s ongoing commitment to the highest standards for current and future product partners.  As the innovation and product gateway of the Prometheus Medical Group of companies, the achievement of ISO 13485 demonstrates the implementation of best practises throughout the product lifecycle of Prometheus’ offerings.

“Realising the International Organisation for Standardisation certification for quality management emphasises our commitment to the development of safe and clinically effective products” states Dr Keith Real, Chief Executive Officer at Prometheus DeltaTech.  “I’d like to thank the team involved that diligently, passionately and professionally set out to advance our company to this level.  This certification is a significant milestone for Prometheus DeltaTech and provides an important foundation to globally expand our business into other clinical applications, whether organically created or brought to us by partners.”

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