ISO 13485 is an internationally recognised quality management standard specifically developed for organisations operating within the medical device sector. It places particular emphasis on quality management, documented processes, traceability, risk management and consistent product and service delivery.

For TruCryo, achieving the certification represents an important step in strengthening the systems and processes behind its range of localised cryotherapy equipment.

The certification comes as the company continues to develop its TruCryo proposition for physiotherapy, sports treatment, rehabilitation and other specialist applications, combining equipment with training, technical support and ongoing customer service.

Jason Peters, Lead Engineer at TruCryo, said: “Achieving ISO 13485 is something we are extremely pleased with. It has required a considerable amount of work behind the scenes, but it gives us a very strong foundation for the next stage of TruCryo’s development. “As we grow, it is important that the processes behind the business develop at the same pace as the products themselves. ISO 13485 gives customers and potential partners additional confidence that quality, traceability and continual improvement are fundamental to the way we operate.”

TruCryo sees the certification as an important stepping stone rather than an end point, supporting further product development, new commercial partnerships and expansion into professional healthcare and treatment markets.

The company is currently developing a network of partners across the UK. It is particularly interested in working with physiotherapists, sports rehabilitation professionals and other organisations looking to introduce localised cryotherapy into their treatment offering.