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
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
Whether preparing for an FDA submission, a CE mark application, or post-market surveillance audits, our technical documentation services help you stay compliant with regulatory standards while minimising the administrative burden on your team.
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.
Clinical Services
We provide a range of services that help manufacturers gather the data needed to bring their devices to market and maintain compliance post-market.
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.
ISO 13485 Medical Device Quality Management Systems (QMS) Certification
Meet national or international regulatory requirements for medical devices and services through ISO 13485 certification.
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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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.
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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.
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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.
