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 customised 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 specialised expertise, scalable resources, and robust quality assurance, you can enhance your regulatory management capabilities while prioritising 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.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 recognised 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 organisational risk go hand in hand.ISO/IEC 42001 Artificial Intelligence – Management System
Build resilience and manage the risks and opportunities associated with AI systems.
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 Organisations Do Differently
ArticleThis white paper examines why CAPA systems often close records without preventing recurrence, tracing breakdowns to investigation quality, risk reasoning, and organisational behaviour rather than procedural gaps. It outlines what differentiates compliant CAPA programmes from those that consistently reduce repeat findings and inspection risk.
Challenges at the Intersection of Medical Device Software and Machine Learning
ArticleMedical device manufacturers increasingly incorporate machine learning (ML) models into their products, significantly enhancing their capabilities. However, integrating ML into the established processes of medical device development introduces challenges due to fundamental differences between traditional software development and ML model development.
What’s Really at Stake When Trade Policy Shifts? For Life Sciences Companies, Everything
BrochureWith the right strategies in place and the right partners, life sciences businesses can mitigate tariff impacts, protect their innovation pipelines, and emerge more resilient in the face of global trade uncertainties.
News and Events
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.
European Commission Puts the Delay to EU MDR Transition Timelines to the Vote
January 11, 2023The European Commission published its proposal paper on the transition provisions for medical devices and in vitro diagnostic medical devices on January 6, 2023, it sets out the new transition deadlines and is a must read for the MedTech industry.European Commission Proposes Delay to EU MDR Transition Timelines
December 20, 2022Since the EU MDR came into force in 2017, large parts of the MedTech industry and notified bodies have warned that the capacities of the notified bodies to issue new certificates could become the decisive bottleneck for the implementation of the EU MDR and the EU IVDR. This fear has solidified in the last five years.
Are You a Medical Device and IVD Expert? Join Our Consulting Team!
August 9, 2021We're recruiting! NSF has several open consulting roles across the globe. We would love to chat with you about your experience and discover how you could be an asset to our organization.
How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
