MDSAP enables a medtech manufacturer’s quality management system to undergo a single regulatory audit to satisfy the requirements of multiple regulatory jurisdictions or authorities.
The company has designed its Nano-Pulse Stimulation technology to deliver nanosecond pulses of electrical energy to clear cells while sparing adjacent non-cellular tissue. It is seeking regulatory clearance of its CellFX system, the first product to use Nano-Pulse technology, to address a broad range of dermatologic conditions.
“On the path to commercializing the CellFX System, MDSAP and ISO-13485 certifications represent important milestones,” said Pulse Biosciences president & CEO Darrin Uecker in a news release. “The MDSAP certification is a significant and necessary step on the path to Health Canada Approval for the CellFX System and with this we remain on track for an approval in the first half of 2021.”