Combination Products
NSF experts help navigate medical device and pharmaceutical compliance. We're leaders in combination products, offering consulting, training, and audits.
Our team of medical device and pharmaceutical experts can assist you in getting your product to market and ensuring that it remains compliant. The combination product landscape is often regarded as a regulatory maze with differing opinions and product definitions. NSF’s team of ex-regulators and industry experts has many years as leaders in this sector, providing consulting, training, and auditing services to companies with combination products.
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.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.
