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.
Addressing Medical Device Quality Systems
Receive tailor-made solutions for your specific needs, including a defined quality plan with program management guidance.
Meeting and Complying With Regulations
Achieve sustainable and compliant quality management systems with our expert team of former regulators and technical experts.
Post-Inspection and Post-Market Response
Draft and submit regulatory responses and reports with the assistance of our highly experienced, global regulatory experts.
Regulatory Services
Receive your customized regulatory strategy from our team of former regulators and technical experts to efficiently bring innovative medical devices, in vitro diagnostics and combination products to market.
Inspection Readiness
Schedule a mock audit or readiness inspection to prepare your team for the regulatory audit and inspection process. Our team of former FDA and MHRA regulatory inspectors provides detailed feedback, strategic advice and inspection support. If requested, we include “hats-on, hats-off” services.
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.
