ISMART Developments
Birmingham, England (ots/PRNewswire)
ISMART Developments Ltd (Birmingham, UK), the leader in flexible, non-invasive light emitting diode (LED) technology, announced that it has received certification under the European Council’s Medical Devices Regulation 2017/745 for its LED anti-acne face mask . ISMART Developments Ltd has reason to believe that they have developed the first domestic LED device to receive this certification on 9th March 2023.
Sue D’Arcy, Chief Executive Officer of ISMART Developments Ltd, spoke about the significance of this company milestone.
European medical device regulators have transitioned from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) to protect the health and safety of EU citizens. The new regulation aims to ensure that manufacturers produce safe products. It is also considered an attempt to take action against those who do not meet the requirements. For our company, safety and effectiveness are important factors in our products. We applaud efforts to raise safety standards for medical devices on the market. Compliance was a daunting task for our company, but we were able to complete it in a short amount of time. In addition, each device that we develop, manufacture and sell is subject to the control of our quality management system MDSAP ISO 13485, which offers our customers security when marketing their products.
ISMART Developments Ltd is the leading manufacturer of LED technology for domestic use. Founded in 2018 by Sue D’Arcy, ISMART is focused on the design and manufacture of flexible silicone LED devices that enable medical light therapy at an affordable price. Since the early ’00s, Sue and her team have been at the forefront of developing LED devices for medical and aesthetic indications. They pioneered conducting pivotal clinical studies to determine the right light parameters for the treatment of acne, wrinkles, skin aging and non-melanoma skin cancer, and developed the first FDA-approved home use device for treating cold sores.
The Acne Treatment LED Face Mask is designed using bi-chip technology to deliver optimized blue and red light wavelengths and intensities that provide safe and effective results for mild to moderate inflammatory acne vulgaris. It is specifically designed to comply with MDR, FDA, TGA and Health Canada and is manufactured in a world class MDSAP ISO 13485 facility. It has been tested, tried and backed by scientific evidence to ensure the best possible results and performance.
View original content: https://www.prnewswire.com/news-releases/ismart-developments-erhalt-als-erstes-unternehmen-die-eu-mdr-zertifizierung-fur-ein-led-gerat-fur-den-hausgebrauch-301808889.html
Press contact:
Sue D’Arcy,
ISMART Development,
+44 (0) 7880 313315,
[email protected],
ismart.health
Original content by: ISMART Developments, transmitted by news aktuell