ISO 13485 certified!

August 31, 2023

We are proud to announce that Spark has been awarded the ISO 13485:2016 certification.

The ISO 13485:2016 certification is the gold standard for quality management in medical device development. Remi Veenman, our business director Medical, imparts his thoughts on the certification: “The certification underscores our steadfast commitment to designing reliable, top-quality products for our clients in the medical device industry. We couldn't be prouder of our team for their hard work and diligence in achieving this prestigious certification.”  

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This certification provides us with a Quality Management System that helps us better manage the traceability of product developments, which is excellent for quality control. The ISO process is a continuous improvement process, which aligns with Spark's values and ethos. 

We are thrilled with the certification as it enables us to provide our partners with better assistance. Additionally, it helps our clients in managing their Quality Management System accountability.  

We are confident that the ISO 13485 certification will not hinder our creativity. Instead, we believe it will do the opposite by giving us more time to focus on creativity since the foundation is strong because we have the framework of procedures in place. 

Thank you to all who have supported us on this journey, and we look forward to continuing to provide innovative and reliable solutions for our clients in the healthcare sector.