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Achieving ISO-13485:2016 MDSAP Certification Affirms the Company’s Quality Management Systems Meet FDA,
The 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
“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
About Pulse Biosciences®
Caution: Pulse Biosciences’ CellFX System and Nano-Pulse Stimulation technology are for investigational use only.
Forward-Looking Statements
All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding regulatory clearance and the timing of regulatory filings or approvals, the ability of the Company to prepare and provide data to regulatory bodies, the CellFX System including the benefits of the CellFX System and commercialization of the CellFX System, the Company’s market opportunity and commercialization plans, and other future events. These statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the
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