Bundle of 6 Courses - Medical Device Single Audit Program (MDSAP) Overview and Country-Specific Medical Devices Regulatory Requirements for United States, Japan, Australia, Brazil, Canada
A comprehensive overview of each countries' Medical Device regulatory framework, including both Premarket AND Postmarket requirements. Learn what it takes to bring a product to market in each country and KEEP it there! You’ll also be introduced to the Medical Device Single Audit Program (MDSAP), and learn how each country is utilizing MDSAP. Includes competency assessments to provide documented evidence for the training requirements.
NSF International’s web-based virtual training course provides the basic knowledge to prepare for MDSAP, helps key personnel realize the urgency regarding MDSAP readiness and offers answers to vital questions direct from global Quality Systems expert, Kim Trautman, a former U.S. FDA official and key member of the original MDSAP development team. Kim also authored and led the implementation of the current U.S. FDA Quality System regulation and is a globally-recognized leader of continuing harmonization efforts for ISO 13485.
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- Links to Other Websites. A Course may contain links to third party websites. Access to any other website linked to the Course is at the user's own risk and NSF is not responsible for the accuracy or reliability of any information, data, opinions, advice or statements found on those websites, and NSF does not exert any editorial or other control over those other sites. NSF provides these links merely as a convenience to You and the inclusion of such links does not imply an endorsement by NSF of any such third party sites or their content.
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- Invalidity. If any of the terms and conditions of this Agreement is adjudged to be invalid, void or unenforceable, the remaining terms and conditions of this Agreement will not be affected thereby. Such invalid provision shall automatically be deemed to be replaced by the lawful provision that most nearly embodies the original intention of the parties as expressed herein, and the remaining terms and conditions of this Agreement will in any event otherwise remain valid and enforceable.
- Entire Agreement. This Agreement, its terms and conditions, as well as such other agreements or documents referenced herein, as each may be amended from time to time, constitute the entire agreement between You and NSF with respect to the subject matter of this Agreement and Your use of the Course, and they supersede all previous communications, representations or agreements, whether oral, written or electronic, between the parties with respect to said subject matter. A printed version of this Agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to the terms and conditions of this Agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.
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