In Vitro Diagnostics
NSF experts have extensive experience with leading IVD manufacturers. We offer a comprehensive suite of services to ensure compliance.
NSF experts have many years of working with the world’s largest and most dynamic in-vitro diagnostic manufacturers. We understand the challenges that manufacturers face in bringing their products to market and ensuring compliance when products are on the market. That is why we offer a comprehensive suite of services to companies in the IVD sector. Our global team can ensure that your product meets the regulatory challenges while your manufacturing processes are compliant.
Explore Our Services
Use of NSF consulting services or attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.
ISO 13485 Quality Management Systems (QMS) for Medical Devices
Demonstrate credibility with a certification to the internationally recognised standard for medical devices, access global markets, streamline processes, and reduce safety risks.Quality Management Services
Our quality management services are designed to help companies develop, implement, and maintain comprehensive QMS frameworks that meet these global standards.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.Audit and Inspection Readiness
Prepare for your next FDA inspection or notified body audit or get experienced support when one is already underway. NSF brings extensive inspection and audit experience, with teams that can include former FDA employees and investigators. We help you identify compliance gaps, strengthen inspection readiness, manage active inspections and respond to inspection findings.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.Clinical Affairs
We provide a range of services that help manufacturers gather the data needed to bring their devices to market and maintain compliance post-market.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.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.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.Internal, Supplier and Audit Programme Management
Our audits identify compliance gaps and opportunities to improve QMS effectiveness. We support planning, execution, reporting and follow-up, with findings focused on compliance and process effectiveness.Technical Documentation and Regulatory Compliance Services
Outsourcing regulatory documentation offers a strategic solution for navigating today’s demanding compliance landscape. By providing specialised expertise, scalable resources, and robust quality assurance, you can enhance your regulatory management capabilities while prioritising product development and market growth.Tariffs and Life Sciences Supply Chain
Is your organisation prepared to navigate operational, sourcing, and regulatory disruption in today’s volatile environment?ISO/IEC 42001 Artificial Intelligence – Management System
Build resilience and manage the risks and opportunities associated with AI systems.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.
How NSF Can Help You
Get in touch to find out how we can help you and your business thrive.
