Regen Lab SA Is the First Company in the PRP Field to Be Successfully Audited under the MDSAP
LE MONT SUR LAUSANNE, VAUD, SWITZERLAND, December 6, 2019 /EINPresswire.com/ — Antoine Turzi, CEO of Regen Lab SA Switzerland, is delighted to announce that the work of Regen Lab’s research team has been selected for the cover of the November 2019 issue of the prestigious Tissue Engineering journal*.
Our work demonstrates that fibroblasts derived from human skin grow almost 10 times faster in medium supplemented with RegenPRP®/Cutecell® than with fetal bovine serum. Growth of the cells in RegenPRP did not affect the genomic stability of the cells.
In addition, Regen Lab becomes the first PRP-based company to be successfully audited under the Medical Device Single Audit Program (MDSAP). This is an important milestone for Regen Lab, as MDSAP is mandatory in Canada since January 1, 2019. Companies that are not MDSAP compliant can no longer commercialize in Canada. At the ICRS conference in October 2019, Dr Anz confirmed that the USA will make MDSAP mandatory in 2020. Other countries are expected to follow.
Regen Lab is proud of meeting the essential conditions for full Freedom to Operate by investing in R&D to create and develop innovative and effective products, with strong patent protection and results published in peer-reviewed journals, while ensuring full regulatory compliance with MDR745 in Europe and MDSAP globally.
*Autologous Platelet-Rich Plasma (CuteCell PRP) Safely Boosts In Vitro Human Fibroblast Expansion
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 MATRIX 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.
Additional information about RegenLab and its patents can be found at Regen Lab patents.
Regen Lab SA
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Regen Lab SA
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Source: EIN Presswire