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
ISO 13485 Medical Device Quality Management Systems (QMS) Certification
Meet national or international regulatory requirements for medical devices and services through ISO 13485 certification.
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.
Clinical Services
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.
Outsourcing Services
Our outsourcing services allow manufacturers to leverage our experience and expertise in areas like clinical trials, regulatory submissions, and quality management, helping reduce the burden on internal teams while ensuring compliance with global standards.
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.
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.
