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.
Tariffs and Life Sciences Supply Chain
Is your organisation 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.
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.
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.

View all webinars (keynotes)

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.

Subscribe now

Our Experts

Our medical device, IVD, and combination product experts can help you to bring new and innovative products to market.

Meet our experts

Resources

NSF Medical Devices Summit 2026
Article
Join medical device manufacturers, regulatory specialists, quality leaders and technical experts in Hamburg, Germany on November 12 for a day of discussion focused on the challenges shaping today's MedTech industry.
Why CAPA Keeps Failing and What Strong Organisations Do Differently
Article
This 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.
Expanding ROI from Your CAPA Programme
Article
NSF’s CAPA services focus on how CAPA is executed in practise. 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.

News and Events

NSF Annual Review and Impact Report 2025 Now Live
April 20, 2026
NSF has published its Annual Review and Impact Report 2025, detailing the organization’s progress over the past year and outlining strategic priorities for 2026.
Read the Story
European Commission Puts the Delay to EU MDR Transition Timelines to the Vote
January 11, 2023
The 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.
Read the Story
European Commission Proposes Delay to EU MDR Transition Timelines
December 20, 2022
Since 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.
Read the Story
Are You a Medical Device and IVD Expert? Join Our Consulting Team!
August 9, 2021
We'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.
Read the Story