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.

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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 recognized 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 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.
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.
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.

Combination Products

Explore Our Services

ISO 13485 Quality Management Systems (QMS) for Medical Devices

Quality Management Services

Post-Market Surveillance Services

Audit and Inspection Services

Regulatory Services

Medical Device and IVD Management Systems Certifications