Trisonics Blog

Trisonics Achieves ISO 13485 Certification

Trisonics Achieves ISO 13485 Certification

 

After many months of hard work and preparation, Trisonics has achieved ISO 13485:2016 Certification. Our team spent countless hours creating and implementing systems that will help give you confidence in every part, service, and system we supply. 

"Trisonics has always been committed to maintaining the highest level of quality and exceeding our customer's expectations. Today, I am excited to announce that we have achieved ISO 13485 certification. As an independent company in an ever-evolving, competitive landscape, Trisonics continues to stay in the forefront by having a top-level quality management system and setting the Gold Standard in ultrasound solutions." - Jen Riner, CEO.

"Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. More and more, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.

ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry." - International Organization for Standardization.

 

Click here to read the full press release.

 

 



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