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 Solution Areas
ISO 13485 Medical Device Quality Management Systems (QMS) Certification
Meet national or international regulatory requirements for medical devices and services through ISO 13485 certification.
Addressing Quality Systems
Receive tailor-made solutions for your specific needs, including a defined quality plan with programme management guidance.
Meeting and Complying With Regulations
Achieve sustainable and compliant quality management systems with our expert team of former regulators and technical experts.
Post-Inspection and Post-Market Response
Draft and submit regulatory responses and reports with the assistance of our highly experienced, global regulatory experts.
Performing Audits
NSF offers a variety of mock audits to help you ensure regulatory readiness. Assess a wide range of regulatory requirements to identify areas of risk and perform due diligence activities, or rely on NSF to support your internal and supplier audit programmes.
Regulatory Services
Receive your customized regulatory strategy from our team of former regulators and technical experts to efficiently bring innovative medical devices, in vitro diagnostics and combination products to market.
Inspection Readiness
Schedule a mock audit or readiness inspection to prepare your team for the regulatory audit and inspection process.
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.
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 nowOur Experts
Our medical device, IVD, and combination product experts can help you to bring new and innovative products to market.
Meet our expertsThe Right Training for Your Team
Our interactive training courses are based on real-world scenarios and designed to help you meet international requirements, no matter where you are located.
Learn more about our training 
Resources
News and Events
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.
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February 2023 Medical Device and IVD News Update
February 15, 2023This month we'll look at key FDA policies, procedures, and practices before, during and after inspections, provide tips for writing effective nonconformity statements during QMS audits, and more.
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January 2023 Medical Device and IVD News Update
January 23, 2023Welcome to our new Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.
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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.
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How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
