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Pulse Biosciences Announces Receipt of MDSAP Certification
Achieving ISO-13485:2016 MDSAP Certification Affirms the Company’s Quality Management Systems Meet FDA, Health Canada and CE Mark Requirements HAYWARD,
About this update from Pulse Biosciences, Inc
[{"type":"text","content":"\nAchieving ISO-13485:2016 MDSAP Certification Affirms the Company’s Quality Management Systems Meet FDA, Health Canada and CE Mark Requirements\n\n HAYWARD, Calif.--(BUSINESS WIRE)--\nPulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company progressing Nano-Pulse Stimulation™ (NPS™) technology, today announced the receipt of Medical Device Single Audit Program certification.\n\nThe Medical Device Single Audit Program (MDSAP) allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory jurisdictions or authorities to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems while minimizing regulatory burden on the industry. The program was developed by the International Medical Device Regulators Forum and currently representatives from The Therapeutic Goods Administration in Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada; Canadian Medical Device Regulations, Japan’s Ministry of Health, Labour and Welfare and Pharmaceutical and Medical Devices Agency, and the U.S. Food and Drug Administration, Center for Devices and Radiological Health participate in the program.\n\n“On the path to commercializing the CellFX® System, MDSAP and ISO-13485 certifications represent important milestones. Certification through these programs validate our ongoing commitment to maintaining the highest quality assurance standards within the medical device industry as required by regulatory authorities across the world,” said Darrin Uecker, President and CEO of Pulse Biosciences. “We are very proud of our teams for this significant accomplishment and for demonstrating the high standards we maintain as we prepare for commercial launch. 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.”\n\nAbout Pulse Biosciences®\n\nPulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve and extend the lives of patients. If cleared, the CellFX® System will be the first commercial product to harness the distinctive advantages of the Company’s proprietary Nano-Pulse Stimulation™ ...