Medical device companies operate in a complex global regulatory environment with continually changing standards. NSF International offers comprehensive consulting, training and education, and testing services to assist medical device companies in navigating U.S. and international regulatory hurdles throughout the total product lifecycle. We have combined regulatory and industry expertise across all therapeutic areas and provide customized consulting services in compliance and remediation, regulatory strategy and market access, quality engineering and validation, quality management systems improvement and patient communications. We also provide training and education as well as analytical testing services.
Due to regulatory impartiality requirements, clients certified by NSF Health Sciences Certification, LLC under the Medical Device Single Audit Program (MDSAP) cannot utilize NSF International’s medical device consulting services. All clients can utilize medical device training and education services.