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. Our team of former FDA and MHRA regulatory inspectors provides detailed feedback, strategic advice and inspection support. If requested, we include “hats-on, hats-off” services.
WHO Prequalifications for IVDs
NSF has expertise in the WHO prequalification process for including products in UN procurement tenders. We assist manufacturers in navigating all assessment stages for prequalification.
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.

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Our Experts

Our medical device, IVD, and combination product experts can help you to bring new and innovative products to market.
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The 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.
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How NSF Can Help You

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