We guide and support our clients in delivering products ready-for-market with the necessary regulatory approvals and clinical data already in place.
We work with you assess the benefits of the project and how to mitigate risks in the development program. We support you in generation of achievable program costings which enable us to deliver high-quality, effective and commercially desirable products.
Our close working relationship with an expert panel of doctors and medical professionals, enables us to design and conduct high quality clinical trials on all devices to support regulatory approval prior to mass-production and commercialisation.
Working with our fully regulated MDSAP ISO 13485 manufacturer, iSmart ensures all products are developed to the highest standard, to meet all necessary regulatory requirements.
The iSmart in-house regulatory team rigorously assesses all aspects of a product, to deliver LED devices for our partners that can carry the necessary global regulatory compliances.
We advise on getting the product ready for market, with all necessary regulations and clinicals. We also carry out bespoke product branding and packaging, with the mandatory, country-appropriate regulation labelling and facilitation of licencing.
iSmart can bring your idea to life.
Brand an existing LED device that is already designed and regulated.
iSmart has a range of fully regulated, high quality, award winning products that can be rebranded. We help you with design and marketing to complement your established range of devices or skincare products, as a lucrative addition to your existing offering.
With iSmart as your partner, you can be assured that the products you are adding to your brand portfolio are the very best.
“iSmart has provided some of the most innovative and revolutionary new products for Refine USA capturing the needs of today’s market. We are fortunate to have found them.”