Meeting the need for safer, more sustainable healthcare
Single-use medical devices are a major source of both financial strain and environmental waste in hospitals. Medsalv, a mission-driven healthcare company operating across New Zealand and Australia, saw an opportunity to tackle this challenge through remanufacturing.
By collecting used devices, restoring them to meet strict performance and safety standards and returning them to hospitals for reuse, Medsalv provides a sustainable, cost-effective alternative. To ensure these operations meet global expectations for safety, consistency and compliance, Medsalv worked with the SGS team to implement a Quality Management System (QMS) certified to ISO 13485.
Medsalv began its ISO 13485 journey in New Zealand, working with us to develop and refine its QMS to meet the requirements. Certification was achieved in 2021.
As the company expanded into Australia, it undertook a further 12-month integration project with our specialist team to bring the new site under the same quality framework. This involved:
In late 2024, we helped Medsalv to successfully extended its ISO 13485 certification to cover both New Zealand and Australia, a key milestone in its regional growth strategy.
Our certification audit process helped Medsalv:
Our auditors also commended Medsalv's robust inspection and testing protocols, strong commitment to staff training and continual improvement, and proactive focus on sustainability, patient safety and regulatory engagement.
With ISO 13485 certification in place, Medsalv has:
Oliver Hunt, Managing Director at Medsalv, said: "Achieving ISO 13485 certification demonstrates our commitment to patient safety, regulatory compliance and operational excellence. It provides assurance to hospitals and regulators that we meet the highest international standards.
"The certification journey wasn't easy, but it made our business stronger and more scalable. The SGS audit reinforced the value of a strong QMS, not just for compliance but for day-to-day effectiveness. It's made our business stronger and more scalable."
For further information, please visit the ISO 13485 Certification web page or contact:
Steven Guyatt
National Business Development Manager
Business Assurance
t:+61 457 008 717
SGS is the world’s leading Testing, Inspection and Certification company. We operate a network of over 2,500 laboratories and business facilities across 115 countries, supported by a team of 99,500 dedicated professionals. With over 145 years of service excellence, we combine the precision and accuracy that define Swiss companies to help organizations achieve the highest standards of quality, compliance and sustainability.
Our brand promise – when you need to be sure – underscores our commitment to trust, integrity and reliability, enabling businesses to thrive with confidence. We proudly deliver our expert services through the SGS name and trusted specialized brands, including Brightsight, Bluesign, Maine Pointe and Nutrasource.
SGS is publicly traded on the SIX Swiss Exchange under the ticker symbol SGSN (ISIN CH1256740924, Reuters SGSN.S, Bloomberg SGSN:SW).
