Kleresca® achieves MDSAP certification
Ballerup, Denmark, December 2018. Kleresca®, a medical technology company focused on the development and commercialisation of a unique biophotonic technology in dermatology, has been certified according to The Medical Device Single Audit Program (MDSAP).
Audited by the National Standards Authority of Ireland (NSAI), Kleresca® has been certified to be compliant with the standard and regulatory requirements for the medical device markets of Australia and Canada. With minor additional audits and approvals, the certification will also apply to Brazil, Japan and the United States.
The MDSAP certification is an add on to the quality management standard ISO 13485 that the company obtained in July 2018.
The certification is an important stepping stone in Kleresca®’s expansion strategy and paves the way for entering new markets going forward.
“We are excited to have secured the MDSAP certification as it gears the company for further expansion into key markets. It is essential to have the basics in place and take the right steps at the right time. So during 2019, we will focus on investigating our operational options for entering the US market”, says General Manager Mikkel Schoedt.
As the FDA (US Food and Drug Administration) is part of the MDSAP programme, the audit report will be available to the administration on demand. However, an additional audit approval will possibly be required to enter the US market when Kleresca® is ready to expand further to the West.
Currently, Kleresca® is developing markets in 10 countries including Italy, Spain, UK, Germany, France, Switzerland, Denmark, Norway, Belgium and Australia.
The company portfolio includes four products: Kleresca® Acne Treatment, Kleresca® Skin Rejuvenation, Kleresca® Rosacea Treatment and Kleresca® Pre-Post. All products are based on an innovative technology that uses fluorescent light energy (FLE) to stimulate the skin’s biological processes.
Visit http://news.cision.com/kleresca/ and www.fb-dermatology.com to learn more about Kleresca®.
Nadia Vega Vasiljev
Global PR and Communication
nvv@kleresca.com
At Kleresca®, we aspire to change the fundamentals of dermatology. Our innovative biophotonic technology represents a unique mode of action that allows us to create a new gold standard within the industry for the benefit of patients worldwide. The Kleresca® biophotonic platform offers non-invasive treatments for both therapeutic and aesthetic conditions using fluorescent light energy (FLE) to stimulate the skin’s own biological processes and repair mechanisms through photobiomodulation (PBM). Demonstrating high safety and efficacy, our technology triggers documented skin repairing benefits for a number of diseases and conditions. The company is headquartered in Dublin, Ireland, and builds on the scientific heritage from LEO Pharma and KLOX Technologies. Kleresca® is currently developing ten (10) markets including Australia, Italy, Spain, France, Switzerland, Germany, Belgium, Denmark, Norway and UK. Kleresca® is also registered as FB Dermatology.
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