The foundation for Mantra Medical Limited was a simple question: Why aren't blood pressure cuffs and stethoscopes cleaned between every patient?
Realising that existing methods of cleaning were far too time consuming for consistent use, a market opportunity for an innovative, faster and easier method was spotted. Through examining other opportunities within the clinical environment the product portfolio was expanded and developed into its present form.
We have established strong commercial partnerships with designers, IP specialists and the Medipex NHS Innovation hub for Yorkshire, as well as good links with healthcare staff in Yorkshire and beyond.
Fripp Design & Research
Fripp Design is our carefully selected professional design partner. We chose them from a short-list of three following competitive tender on the basis of quality of previous work, geographical location, ISO registration and perceived ability to comply with our ISO 13485-based quality system. Fripp Design have previous experience producing devices for the medical market including projects to assist reconstructive surgery, as well as extensive experience in general design. We have a superb working relationship with Fripp Design and look forward to furthering our relationship as we develop our products.
Withers & Rogers LLP
Withers & rogers LLP is one of the leading Intellectual Property law firms in the UK andEurope. All our intellectual property applications have been made by and after consultation with one of their top attorneys in Sheffield. We have regular contact in regard to the status of our applications and have established a solid and trusted working relationship.
Allotts Chartered Accountants
Allotts of Rotherham provide top-level accountancy services to Mantra Medical. In addition, they have been extremely supportive with general business advice and offer a range of useful contacts. As with our other partners we consider our relationship with Allotts to be productive, important and very valuable.
Medipex is the NHS Innovation Hub for Yorkshire and Humberside and has been a key partner in linking with trusts and infection control departments, and therefore in conducting our market research. They have also provided general support and advice often on a voluntary basis, and have been instrumental in enhancing our understanding of NHS Procurement streams and marketing strategies. We regard Medipex as an important partner on an ongoing basis.
Ilett & Clark Solicitors
Ilett & Clark Solicitors is a niche commercial and private client practice. For a quarter of a century the firm has balanced the use of leading edge legal innovation with a friendly and personal service. It was the first firm in the East Midlands to be simultaneously awarded the Law Society's Lexcel badge of excellence and Investors in People and one of the first firms nationally to achieve the Conveyancing Quality Standard.
All our products are developed within a quality assurance framework based around ISO 13485. We are preparing for an initial compliance audit to be conducted by DNV Certification. All our design partners are ISO 9001 registered, and our principal design partner is working towards ISO 13485. A copy of our quality assurance manual is available on our website.
We are fully aware of our commitments under the Medical Devices Directive, and the main requirement to be met during design is to ensure that quality and safety of all devices is prioritised.
Our approach to quality is further demonstrated by us having already invested in proof of concept work for the cuff cleaner project with the microbiology department at Sheffield University.
The overall responsibility for quality assurance falls to the Director for Management Systems and QA, who is answerable to the board. The reporting, resolution and documentation procedure for adverse events is defined in our ISO 13485-based quality system, and risk management is an agenda item at every board meeting.
Sub-contractor selection was competitive and based around compliance with ISO standards and scrutiny of their previous work for the medical market. Fripp Design's primary focus is now medical device development and they have previous success in this field, including products for Boots and work constructing models to assist reconstructive surgery.