Medical Devices
NSF offers consulting, training, and auditing for global med-tech firms. Navigate regulations, mitigate risk, and ensure compliance with expert advice.
NSF's range of consulting, training, and auditing services for medical device, IVD and combination product manufacturers are called upon by companies globally. Our ability to navigate the maze of ever-changing regulations enables us to deliver consistent outcomes for client companies.
Mitigate risk, ensure compliance with international and FDA regulations and standards, and apply effective quality systems with expert advice from NSF.
Explore Our Solutions
Use of NSF consulting services or attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
Medical Devices and IVDs Training
Expert-led training that gives you the confidence to apply your knowledge from day one.Custom, In-house Medical Device and IVD Training
Tailored, in-house training and fully customized workshop formats for medical device and IVD teams. Together, we define the content, level and format that best support your team’s competence needs.Regulatory Services
Regulatory services build the framework for ensuring compliance, safety and effectiveness of medical devices and IVDs. Achieve sustainable and compliant quality management systems with our expert team of former regulators and technical experts.Audit and Inspection Services
Our audit and inspection readiness services are designed to prepare manufacturers for every stage of the audit process. We help you assess your current compliance status through thorough gap assessments and mock audits.Outsourcing Services
Our outsourcing services allow manufacturers to leverage our experience and expertise in areas like clinical trials, regulatory submissions, and quality management, helping reduce the burden on internal teams while ensuring compliance with global standards.Technical Documentation and Regulatory Compliance Services
Outsourcing regulatory documentation offers a strategic solution for navigating today’s demanding compliance landscape. By providing specialized expertise, scalable resources, and robust quality assurance, you can enhance your regulatory management capabilities while prioritizing product development and market growth.Quality Management Services
Our quality management services are designed to help companies develop, implement, and maintain comprehensive QMS frameworks that meet these global standards.Tariffs and Life Sciences Supply Chain
Is your organization prepared to navigate operational, sourcing, and regulatory disruption in today’s volatile environment?Manufacturing Services
Our manufacturing services cover the entire product lifecycle, providing support from the initial design phase through to ongoing process validation and continuous quality improvement. We assist with design transfer, ensuring that all design inputs are accurately translated into production specifications.Post-Market Surveillance Services
Our PMS services extend beyond just meeting reporting obligations. We offer continuous monitoring of real-world data, including adverse event reports, field safety corrective actions (FSCAs), and recalls. These activities help identify trends that could affect the safety and performance of devices.Emerging Regulations and Technical Support Services
Our emerging regulations and technical support services provide the expertise needed to navigate these evolving frameworks and maintain compliance in an ever-changing environment.Design and Development Services
Our quality management services are designed to help companies develop, implement, and maintain comprehensive QMS frameworks that meet these global standards.ISO 13485 Quality Management Systems (QMS) for Medical Devices
Demonstrate credibility with a certification to the internationally recognized standard for medical devices, access global markets, streamline processes, and reduce safety risks.Medical Device and IVD Management Systems Certifications
Whether you produce medical devices or IVD products, help mitigate risk and protect your business with NSF-ISR, including certification to ISO 13485.Clinical Affairs
We provide a range of services that help manufacturers gather the data needed to bring their devices to market and maintain compliance post-market.ISO 45001 Occupational Health and Safety Management System
Create an environment where workplace health and safety and reduced organizational risk go hand in hand.ISO/IEC 42001 Artificial Intelligence – Management System
Build resilience and manage the risks and opportunities associated with AI systems.Regulatory and Quality Support for Life Sciences Legal Teams
NSF partners with legal teams to assess regulatory risks, remediate compliance gaps and support M&A due diligence across pharmaceuticals, medical devices, IVDs and biologics.
Webinars (Keynotes): Medical Device and IVD Compliance
Free, expert-led online sessions covering regulatory, quality, and technical topics for medical device and IVD manufacturers, with a focus on practical compliance and real-world application. Live Q&A is included, with recordings available to watch at any time.
Subscribe to Our Newsletter
Get the latest Medical Device and IVD industry news straight to your inbox each month as well as useful articles and resources, expert advice, training and events for your calendar.
Our Experts
Our medical device, IVD, and combination product experts can help you to bring new and innovative products to market.
Resources
Why CAPA Keeps Failing and What Strong Organizations Do Differently
ArticleThis white paper examines why CAPA systems often close records without preventing recurrence, tracing breakdowns to investigation quality, risk reasoning, and organizational behavior rather than procedural gaps. It outlines what differentiates compliant CAPA programs from those that consistently reduce repeat findings and inspection risk.
Expanding ROI from Your CAPA Program
ArticleNSF’s CAPA services focus on how CAPA is executed in practice. This combines a review of existing CAPA records with structured training and facilitated workshops, delivered on-site or virtually, to identify and correct systemic weaknesses.
QMSR in Force: What FDA Is Now Evaluating During Medical Device Inspections
ArticleFDA inspections are now being conducted under QMSR and Compliance Program 7382.850. This paper examines how that shift is playing out in inspection practice and where quality systems are being tested.
News and Events
NSF To Offer In-Person GMP and Regulatory Compliance Courses at SupplySide Global 2026
July 13, 2026NSF is offering a comprehensive GMP and regulatory compliance training program of classroom-based courses for dietary supplement industry professionals at SupplySide Global 2026.
NSF Annual Review and Impact Report 2025 Now Live
April 20, 2026NSF has published its Annual Review and Impact Report 2025, detailing the organization’s progress over the past year and outlining strategic priorities for 2026.
Join NSF at RAPS Convergence 2023
September 12, 2023This year’s gathering of regulatory affairs professionals will take place in Montréal, QC Canada on October 3–5, 2023.
How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
