ISO 13485:2016 reinforces quality and compliance
LocaMed successfully completes ISO 13485:2016 Surveillance Audit
LocaMed is delighted to announce the successful completion of our recent ISO 13485:2016 surveillance audit, reaffirming our ongoing commitment to the highest standards of quality management in the distribution of medical devices.
The audit, conducted by an independent accredited certification body, confirmed that LocaMed’s quality management system continues to meet the rigorous requirements of ISO 13485:2016 – the internationally recognised standard for medical device quality systems.
Lawrence Brookfield, Regulatory Director, says: “This achievement is a testament to the dedication of our entire team to uphold excellence, patient safety and regulatory compliance. It reinforces our position as a trusted partner in the healthcare sector and validates the robust systems and procedures we have in place.”
Considered the primary standard for regulatory compliance, ISO 13485:2016 is designed to ensure medical devices are safe and meet customer and regulatory needs throughout their lifecycle. The surveillance audit is part of a regular review cycle that ensures certified organisations maintain ongoing compliance.
LocaMed first achieved ISO 13485:2016 certification in April 2016, and this successful audit reflects our continued focus on process improvement, risk management and delivering quality products to the global market.
As we continue to expand and innovate, maintaining the highest standards remains a top priority for the LocaMed team. This milestone supports our ongoing commitment to compliance and continuous improvement, as we continue our mission to improve patient outcomes through reliable, safe and effective medical solutions.
