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

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.

Our Experts

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

Meet our experts

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.

Learn more about our training

Resources

Post Market Surveillance: What You Need to Know to Ensure Patient Safety

Launching a medical device into the market is significant, but the work does not stop there. It is the start of a vital, ongoing commitment to ensure these devices meet the evolving needs of patients and healthcare providers.

Navigating New FDA Regulatory Terrain for Laboratory Developed Tests (LDTs)

The U.S. Food and Drug Administration (FDA), has reclassified Laboratory Developed Tests (LDTs) as medical devices. Critical insights and strategies from leading industry experts on how to navigate the FDA's new LDT regulations.

Why You Should Use the Three Cs Systems Approach to Pharma Remediation

When it comes to your remediation project, learn about the three key success factors that help assure a positive outcome.

News and Events

February 2023 Medical Device and IVD News Update

February 15, 2023

This 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.

January 2023 Medical Device and IVD News Update

January 23, 2023

Welcome 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.

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.

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.

How NSF Can Help You

Get in touch to find out how we can help you and your business thrive.