RegenLab Becomes the First Company Successfully MDSAP Audited In The PRP field.
Posted Oct 16, 2019.
Le-Mont-sur Lausanne, October 3, 2019.
RegenLab are delighted to announce that they are the first autologous PRP system to be successfully audited under the stringent Medical Device Single Audit Program (MDSAP).
MDSAP is a rigorous global harmonised auditing and monitoring procedure for medical devices with three audit phases over a period of three years. It allows the manufacturer to undergo one audit that will be accepted by all regulatory authorities participating in the program. There are currently 5 countries participating in MDSAP with Europe as observer: Australia (TGA), USA (FDA), Canada (Health Canada), Japan (MHLW/PMDA) and Brazil (ANVISA).
It is expected that MDSAP member countries will declare MDSAP as compulsory for their markets in the near future. Companies with non-conforming quality systems will therefore be banned from several countries simultaneously.
RegenLab are proud to demonstrate their market leading quality and safety standards by paving the way in regulatory compliance in the PRP and Cell Therapies industry.
About RegenLab: RegenLab is a leading innovator of medical devices for the preparation of platelet rich plasma (PRP), which it markets under the well-recognized REGENLAB®, REGENKIT® and CELLULAR MATRIXTM brands. RegenLab remains committed to providing pyrogen-free devices of the highest safety & efficacy, as well as protecting physicians through enforcement of its intellectual property rights.