Clearwater Clinical Limited recently passed the ISO 13485 inspection for its ClearScope Endoscope Adaptor, a Class I medical device which enables full HD Video Recording using an HD smart phone on any endoscope. StarFish Medical supported Clearwater with a Quality Management System (QMS) solution that would satisfy ISO 13485 QMS requirements for Class I medical devices.
Julian Bromwich, BSc, Clearwater Clinical Chief Technical Officer: “StarFish Medical is very knowledgeable in regulatory and quality assurance. StarFish personnel went above and beyond the scope of our work by freely sharing advice and helping us gain “medical device thinking.” Their team explained core concepts clearly with lots of useful examples and templates. StarFish helped us customize our quality documents and easily accommodated our evening availability.”
Matthew Bromwich MD, FRCSC, BSc, Clearwater Clinical Chief Executive Officer: “The cost of creating a QMS is substantial for a small company like Clearwater. We definitely got great value. Our work with StarFish Medical enabled us to pass the ISO 13485 inspection and set up our QMS before hiring a full-time quality person.”
Clearwater Clinical Limited designs and manufactures innovative medical-grade devices and surgical equipment. Clearwater Clinical management and scientific professionals successfully built a sustainable business and reputation making use of government and academic grants. Their popular DizzyFIX is a Class I medical device and an effective and natural treatment for vertigo and dizziness due to BPPV.