Consulting - Our team brings innovative medical device, IVD and combination products to market with our consulting and training services.
Establish, audit or remediate your quality systems with guidance from our team of former regulators.
Our experts help you prepare for market, mitigate risk and achieve sustainable compliance with country-specific regulations and international standards.
Training - Professional medical device training is essential in developing your team's expertise, maintaining regulatory compliance and helping ensure smooth operations.
NSF provides in-person, virtual and on-demand regulatory and quality medical device courses and professional qualifications. NSF's medical device courses are highly interactive and based on real scenarios, helping you meet international requirements throughout the product lifecycle.
We can bring all of our courses in-house and deliver them to your wider team to address unique needs.
Find out more about the courses we offer and the flexibility in how we can deliver our training in the products and services tab – training and education.
About NSF International
NSF International protects and improves global human health. Manufacturers, regulators and consumers look to us to facilitate the development of public health standards and provide certifications that help protect food, water, consumer products and the environment.
Products & Services
Developing and Improving Quality Management Systems
Establish, maintain or remediate your quality management system with the help of our medical device consultants.
Getting Ready for Market
Prepare for market launch by conducting clinical trials, developing regulatory filing strategies and ensuring inspection readiness through training and auditing.
Work with our team of former regulators and industry experts to audit your quality systems, conduct clinical trials, prepare for inspections and file regulatory submissions in order to bring your products to market.
Respond to adverse regulatory inspection findings, build a compliant quality system and avoid future problems with a custom remediation plan.
Wherever you are in the product lifecycle, NSF provides solutions and expert guidance. Conduct rescue trials, respond to adverse regulatory inspection findings, build a compliant pharmaceutical quality system or create effective corrective and preventive actions (CAPAs) as part of your remediation plan.
Training and Education
Our medical device educational courses are highly interactive and based on real scenarios.
Learn in your preferred format:
Courses cover the following topics:
Quality Management Systems and Good Manufacturing Practices
Get the tools to ensure your product complies with international standards and regulations. Our diverse training programs teach you how to implement and apply global guidelines through all stages of the product lifecycle.
Courses include U.S. quality systems and combination products, risk management, CAPA deviation and inspection readiness courses.
Country-Specific Regulatory Training
Bringing a product to market in multiple countries requires understanding regional differences and complying with all regulations. Our training offering includes ISO standards courses.
Courses cover the United States, Canada, Brazil, Japan, China and Australia, and the European Union Medical Device Regulation (EU MDR) and European Union In Vitro Diagnostic Device Regulation (EU IVDR).
Market Access Regulatory Training
Understanding the legal and regulatory framework for developing, marketing and distributing medical devices can be challenging. Covering everything from how the U.S. Food and Drug Administration (FDA) classifies medical devices to preparing technical files, our experts are here to help.
Auditor Training for Medical Devices
Today's medical device auditor needs auditing skills, technical skills and up-to-date knowledge of the latest regulatory requirements. Meet these needs with our interactive courses.
Courses cover internal auditor training for the EU MDR, EU IVDR, MDSAP, and a popular CQI and IRCA Certified Lead Auditor Program.
In-House Training for Medical Device Manufacturers
We can bring our medical device courses in-house and deliver to your team to address your unique requirements. NSF's medical device experts will work with you to recommend the right course from our catalogue — or develop anything from a single session to a multi-component program.
Make sure your IVD complies with the IVDR requirements so it can remain on the market after the transition period ends on May 26, 2022.
After a challenging four years of preparation for the EU IVDR, there are just 11 months left on the clock. However, after facing the global COVID-19 pandemic in 2020, is industry ready to meet the IVDR requirements? MedTech Summit in association with NSF conducted a huge survey of medical device and IVD professionals across Europe and the world to discover the industry's readiness for the IVDR, their biggest challenges and how industry insiders are tackling them.