Cornwall based medical mattress manufacturer Squirrel Medical has achieved certification to ISO 13485:2016, the international standard which specifies requirements for a quality management system (QMS) involved in one or more stages of the life cycle of a medical device.
The company’s founders had become aware of the serious health consequence of inadequate mattresses for both care home residents and people confined to beds in their own homes. The next 16 years were spent in intensive research and development of an innovative new design of mattress which uses a series of air tubes that sequentially and slowly apply and relieve pressure against the skin tissue, stimulating endothelial function and improving general circulation without causing discomfort or disturbed sleep.
The certification, which represents the culmination of 19 years of research and development for its ‘Vestims’ mattress, has enabled the company to take the new mattress to market in the UK. Doing so requires registration with the MHRA (Medicines and Healthcare Products Regulatory Agency), in turn needing an accredited quality management system specifically designed for the manufacture of medical devices as part of the UK Medical Device Regulations 2002. The NHS now also specifies ISO 13485:2016 for hospital applications, opening exciting new direct selling opportunities for the company.
SGS was selected by Squirrel Medical as its auditing supplier as it was already Notified Body for a research partner certified as meeting the requirements of Directive 93/42/EEC, as well as being audit partner for the mattress’s outsourced manufacturer in Taiwan.
Founder and Sleep Health Scientist Gary Baker says: “The SGS team including the initial customer contact, internal lead auditor trainers and the two respective auditors, had an extremely high level of competence, which means that they were always clear in their communication and were able to point to the most effective solution. They were very helpful, leading us through the process and explaining how to resolve any issues in the easiest and most effective way. We have pulled together our respective work processes with the result of improving efficiency and productivity.”
He adds: “I have no hesitation in recommending SGS to anybody looking to seek ISO 13485 accreditation and have indeed done so.”
Of the standard itself, Baker says: “ISO 13485 is a quality management system that really works, it’s brilliant. I have to admit that initially we were skeptical, but it has been well thought out by experts and has improved our processes and increased our productivity.”
You can read a detailed account of the journey and how certification has benefited the business here.
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