ISMART Developments first to receive EU-MDR certification for home use LED device
BIRMINGHAM, England, April 27, 2023 /PRNewswire/ -- ISMART Developments Ltd (Birmingham, UK) the leader in flexible non-invasive Light emitting Diode (LED) technology announced that they received certification to European Council Medical Device Regulation 2017/745 for their LED acne facemask. Granted on March 9th, 2023, ISMART Developments Ltd believe they are the first LED device for home use to receive the certification.
Sue D'Arcy Chief Executive Officer of ISMART Developments Ltd spoke about the importance of this company milestone.
The European Medical Device authorities have been moving from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) in a bid to protect the health and safety of EU citizens. The purpose of the new regulation is to ensure that manufacturers produce safe products and attempt to govern those that do not comply. As a company safety and efficacy are important factors in our products and we welcome the efforts to raise the safety standards of medical devices in the market. Compliance has been a formidable task for our company, but we have achieved this in a short period of time. In addition, every device we design, manufacture and distribute is under the control of our MDSAP ISO 13485 Quality Management System, offering our customers peace of mind when commercializing their products
ISMART Developments Ltd are the leading manufacturer of home use LED technology. Founded in 2018 by Sue D'Arcy ISMART focuses on the development and manufacturing of flexible silicone LED devices, delivering medical grade light therapy at an affordable price. Since the early 00's Sue and her team have been at the forefront of developing LED devices for both medical and aesthetic indications pioneering pivotal clinical studies identifying the correct light parameters for the treatment of acne, wrinkles, photoaging, non-melanoma skin cancer and developing the first FDA cleared home use device for the treatment of cold sores.
The LED acne facemask has been developed using bi chip technology to deliver optimized wavelengths and intensities of blue and red light, delivering safe and efficacious results in mild to moderate inflammatory acne vulgaris. Developed specifically to MDR, FDA, TGA and Health Canada and manufactured in a world class MDSAP ISO 13485 facility it has been tested, proven, and is backed by peer-reviewed science to ensure the best possible outcomes and performance.
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