Dermatological device developer Kleresca said today that it has been certified by the Medical Device Single Audit Program (MDSAP), boosting its plan to enter new markets.
The audit gave Kleresca regulatory clearance to enter 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, according to the company.
MDSAP was developed by the International Medical Device Regulators Forum to conduct regulatory audits of quality management systems. Kleresca also obtained the ISO 13485 obtained the quality management standard in July and won CE Mark approval in the European Union for its biophotonic dermatological technology platform in August.
The Kleresca biophotonic system uses fluorescent light energy to stimulate biological processes and repair mechanisms in the skin, the company said.
“We are excited to have secured the MDSAP certification as it gears the company for further expansion into key markets,” said GM Mikkel Schoedt in a company statement. “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 U.S. market,”
The MDSAP audit report will be available to the FDA, which is part of the program, but the company may need additional audit approval to enter the U.S. market, the company said.
Kleresca makes treatments for acne, rosacea, skin rejuvenation, and to prepare the skin for high-energy or invasive procedures. It is developing markets in Italy, Spain, the United Kingdom, Germany, France, Switzerland, Denmark, Norway, Belgium and Australia.
