We completed the full design, development, manufacturing, CE marking, FDA Registration and USA launch of a sterile self-aid urology system in 18 months. Securing regional and major national distribution contracts, key opinion leadership (KOL) sponsorships and adoption at a leading rehabilitation hospital.
Taking an existing product idea, we used our expertise to redesign the product, manage the full verification, validation, usability assessments and safety accreditation of an electronic monitor and wearable device.
Following the set up of the clean-room manufacturing in Asia, we gained HCPCS Reimbursement coding and managed the full product launch and supply chain. Obtaining ISO13485:2003 and ISO13485:2012 accreditation, CE Marking and FDA Registration on behalf of our client.
During an unannounced CE audit of Medtechtomarket, the technical design history and quality management files were audited as part of the CE marking process during customer due diligence and passed a 4-day FDA inspection.
The product was launched in the USA and was a finalist in the 2015 Home Medical Equipment Retail Product awards and has featured in several high-profile trade and disability user publications.
The company signed a number of national and regional distributors, wholesalers and sales representatives and the technology was adopted by the top rehabilitation hospitals throughout the USA. The product was well received and supported by high profile KOL endorsements including a former Gold Medal Paralympian athlete, along with user and industry experts.
