We are delighted to announce that we have officially achieved ISO 13485 certification, marking an important milestone for our business and reinforcing our ongoing commitment to quality, compliance and continual improvement.

Following a challenging but hugely successful four-day audit conducted by NQA, we have now received our official ISO 13485 certificate – an achievement we are incredibly proud to celebrate.

A Commitment to Quality

ISO 13485 is an internationally recognised quality management standard specifically developed for organisations involved in the medical device industry. Achieving certification demonstrates that we hold a robust Quality Management System to consistently meet applicable regulatory requirements and maintain high standards throughout our operations.

The four-day audit provided an opportunity to demonstrate the processes, procedures and standards that underpin our day-to-day operations, as well as the dedication and professionalism of the people behind them.

Successfully completing the process has given us further confidence in the strength of our Quality Management System and the foundations we have in place to support the future of the business.

An Achievement Built on Teamwork

While the certificate may have our company name on it, this achievement belongs to our entire team.

Securing ISO 13485 certification has required hard work, collaboration and an incredible level of attention to detail across the business. Every team and department has played a role in maintaining the standards and processes that enabled us to achieve certification.

We are extremely proud of the commitment shown by everyone involved and would like to say a huge thank you and congratulations to the entire team.

What ISO 13485 Means for Us

Achieving ISO 13485 is much more than gaining a new certificate. It represents another important step in the continued development of Silvalea and provides a strong foundation for our future growth.

For our customers and partners, it provides further assurance of our commitment to maintaining robust quality processes and consistently high standards across our operations.

For the business, it strengthens our position within the medical device industry and supports our ambitions as we continue to develop our products, capabilities and presence within the patient care market.

Most importantly, it reflects a commitment that has always been central to Silvalea and Savaria Patient Care: delivering quality solutions that healthcare professionals, care providers and patients can depend on.

Building on Our Success

We are incredibly proud to have reached this milestone, but our focus doesn’t stop here.

ISO 13485 places continual improvement at the heart of quality management, and we look forward to building on the strong foundations already established as we continue to evolve and grow.

Once again, thank you and congratulations to everyone involved, with a special thank you to Joanna (Asia) Waszczuk, Compliance Manager, and Julie Robertson, Technical and Product Executive, for their hard work throughout the audit and their continued dedication to maintaining the highest standards of compliance and quality.

This is a success for the whole team – and one we are very proud to celebrate together.