Our expertise and knowledge of IP allows your business to operate with certainty.
We help our clients build, maintain and exploit strong Intellectual Property portfolios to foster their unique competitive advantage, minimize their exposure to IP risk and maximize their return on IP investment.
Our consultants bring the information, skill and experience needed to navigate through complex IP issues to help your business make sound and strategic decisions.
With over 20 years’ experience in medical device regulatory services iSmart has all the expertise necessary to guide you in your regulatory implementation strategy. In an ever-changing regulatory environment, it is important to choose a partner who stays ahead of the market requirements.
New devices or new indications always require robust clinical trials to support successful submissions to the appropriate regulatory bodies. We can support clinical evidence collection, design protocols and guide you in the choice of partner to conduct a successful clinical study.
Our clinical research and quality team can help you navigate the post -market clinical studies in accordance with EU, MDR, 2017/745.
MDSAP ISO 13485 Quality
Every iSmart process is under the control of our MDSAP ISO 13485 Quality Management System covering design, manufacturing and distribution. This is our USP and something iSmart are immensely proud of; achieving all three stages of MDSAP offers customers peace of mind when commercialising their products.
Our award-winning products are designed by the specialised team in state-of-the-art laboratories at iSmart Head Office in Birmingham, UK.
Manufacturing takes place in our world class MDSAP ISO 13485 facility, which means we can tightly control quality at every level. This rigorous attention to detail is supported by a range of third-party audits and independent international standards. Our lean manufacturing program ensures minimal waste and highly efficient production without compromising quality or safety.
We are acutely aware of the responsibility we have, both to our partners and to the end-user. We work closely with the FDA and other authorities in evolving the regulatory framework, to ensure all our marketed LED devices are both safe and effective for consumers and patients.
Everyone at iSmart Developments Ltd cares passionately about creating quality products. It is this passion that drives our commitment to high quality manufacturing and product excellence.
“I cannot recommend highly enough partnering with iSmart for the development and marketing of LED products.Innovative, professional, trusted – their core focus is the success of your product.”