Medsalv: Driving Quality, Safety & Sustainability with ISO 13485 Certification

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.

A two-country, multi-year certification journey

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:

• Aligning operations and procedures across both countries
• Managing regulatory differences between jurisdictions
• Ensuring consistent risk management and traceability across the supply chain

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.

Strengthening systems and unlocking value

Our certification audit process helped Medsalv:

• Reinforce its risk-based approach to quality and compliance
• Enhance supplier management and traceability
• Improve documentation and process control
• Streamline reporting and operational efficiency

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.

Market confidence and future growth

With ISO 13485 certification in place, Medsalv has:

• Built greater trust with hospitals, clinicians and procurement teams
• Positioned itself to expand into new healthcare markets
• Strengthened its brand as a leader in sustainable healthcare innovation
• Demonstrated that remanufactured medical devices can meet, and exceed, global expectations

Committed to patient safety and compliance

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