Medical Devices Training Publications
Check out the latest publications for Medical Devices Training.
Latest Publications
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The Do’s and Don’ts of Responding to Deficiencies During FDA Premarket Submission Review
- 3 months ago
The majority of medical device companies that submit FDA premarket submissions, including 510(k)s and premarket...
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White Paper: 2017 – A Year in Review of Medical Devices
- 3 months ago
Regulatory affairs professionals work in a dynamic environment and 2017 was no exception. While the...
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White Paper: Combination Products – Inspection Readiness and Outcomes
- 4 months ago
Whether you are preparing for a medical device, pharmaceutical or combination product inspection, proper preparation...
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MDSAP Portfolio of Services
- 7 months ago
The Medical Device Single Audit Program (MDSAP) allows device manufacturers to streamline regulatory compliance for...
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White Paper: New EU Medical Device Regulation Adopted April 5th - Impacts Examined
- 1 year ago
This white paper examines the new EU medical device regulations and summarizes the perspectives of...
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White Paper: Analytical Methods Needed for Combination Pharmaceutical/Medical Devices
- 2 years ago
While combination pharmaceutical/medical devices have the potential to fulfill major unmet medical needs, they also...
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EU Medical Device Regulations - Are You Prepared for the Impact?
- 2 years ago
To assist companies which are currently or in the future intend to place medical devices...
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The “Catch-Up” 510(k) - A Submission Often Overlooked (published in RAPS Regulatory Focus)
- 2 years ago
The majority of medical devices in the U.S. are brought to market through the 510(k)...
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White Paper: Combination Products: A 40 Year Regulatory Evolution
- 3 years ago
Since the first combination products came under the Food & Drug Administration’s purview over 40...
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Clinical & Regulatory Strategy and Submissions Consulting
- 3 years ago
NSF Health Science Medical Devices’ regulatory team provides a range of specific services to meet...
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International Services: European Expertise
- 3 years ago
Learn about NSF Health Sciences Medical Devices' European-based experts and what services they offer.
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Quality Systems Compliance, Remediation and Auditing
- 3 years ago
Learn more about quality systems compliance, remediation and auditing from NSF Health Sciences Medical Devices...
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White Paper: Regulatory Overview of Proposed LDT Framework
- 3 years ago
In 2014, the U.S. Food & Drug Administration took the first actionable step toward enforcing...
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Medical Devices Total Product Lifecycle Solutions
- 4 years ago
Learn more about total product lifecycle solutions from NSF Health Sciences Medical Devices Consulting. We...
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EU Medical Devices QP Prospectus
- 4 years ago
The QA/RA environment is becoming increasingly complex and recent EU legislation advocates placing qualified QA/RA...