IP & regulatory services
iSMART Developments fully appreciates that an intellectual property review and a well-defined regulatory route are the most critical aspects of all new product development. We rigorously emphasise to our partners that without a fully regulated product, commercialisation is not sustainable.
Intellectual Property
Our expertise and knowledge of IP allow your business to operate with certainty. We help our clients build, maintain and exploit strong Intellectual Property portfolios to foster their unique competitive advantage, minimise their exposure to IP risk and maximise 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.
Regulatory Services
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.
Clinical Trials
MDSAP ISO 13485 Quality Management System
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 is immensely proud of; achieving all three stages of MDSAP offers customers peace of mind when commercialising their products.
What We Can Offer You
Product Range
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