NSF International acquires Prosystem

NSF International recently acquired German medical device consulting firm Prosystem AG, expanding its medical device consulting services into Europe. The company’s acquisition helps expand medical device business into Europe and allows NSF International to meet an increasing demand for medical device consulting, education and training services in Europe. It also allows NSF International’s customers to

NSF on path to become MDSAP Auditing Organization

NSF International’s NSF Health Sciences Certification subsidiary recently announced that it’s on the path to becoming a Medical Device Single Audit Program (MDSAP) Auditing Organization. NSF said July 11 that the MDSAP Regulatory Authority Council had accepted its application, the first of three steps for NSF Health Sciences Certification to become authorized to conduct MDSAP audits. Canada is

5 leadership lessons from women in medtech

Among the medtech companies of the world, women hold a variety of leadership positions — like Cindy Kent, who is the president and general manager of 3M’s Infection Prevention Division, and Sandi Peterson, who is the executive VP and group worldwide chairman at Johnson & Johnson. Women, however, continue to be underrepresented in the top

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How to respond to FDA Form 483s and warning letters

FDA issues hundreds of Form 483s and dozens of warning letters annually. What should you do if one shows up on your desk? Kristen Grumet, NSF International There are many reasons medical device manufacturers receive warning letters from the U.S. FDA: Failing to maintain proper documentation, overlooking or not completely investigating customer complaints, incomplete corrective

New CQI/IRCA-Certified lead auditor training based on ISO 13485 and International MDSAP

NSF International, a global public health and safety organization, is now offering QMS Lead Auditor Training based on both ISO 13485:2016 and international Medical Device Single Audit Plan (MDSAP) requirements. The five-day training program is the first international MDSAP- and ISO-compliant medical device auditing course to be certified by the Chartered Quality Institute (CQI)/International Register of Certificated