Meeting and Complying With Regulations
NSF International provides expert compliance solutions to medical device manufacturers, importers, distributors and others.
Our expert staff of former regulatory officials and industry experts combines global regulatory knowledge with industry best practices to help achieve sustainable and compliant quality management systems.
Our practical and methodical approach identifies and addresses deficiencies at their root cause, and clearly communicates opportunities for improvement. In addition, our experts can help propose and develop appropriate procedures and metrics—with linkages between the quality management system subsystems—that promote and support continuous improvement, resulting in sustainable compliance.
We can assist with:
- Development, implementation and maintenance of quality management systems
- Audits and gap assessments of quality management systems
- Remediation of regulatory inspector/auditor findings and outcomes
- Face-to-face and virtual quality management system training of industry colleagues
- Clinical support throughout the lifecycle of the device
Our expertise includes:
- Australian quality management system requirements of the conformity assessment procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3)
- Brazilian Good Manufacturing Practices (RDC ANVISA16/2013)
- Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169)
- U.S. FDA 21 CFR Part 820 (Quality System Regulation)
- U.S. FDA 21 CFR Part 4 (Regulation of Combination Products)
- Regulation (EU) 2017/745 (EU MDR)
- Regulation (EU) 2017/746 (EU IVDR)
- ISO 13485 (Medical devices – Quality management systems – Requirements for regulatory compliance)
- ISO 14971 (Medical Devices – Application of risk management to medical devices)
Ready to Begin the Process?
Contact us with questions or to receive a quote.
News and Events
NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training
To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.
NSF International’s Health Sciences Team Joins Fight to Save Lives With More Ventilators
NSF International’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.
NSF Launches New IVD App
Special Session of Legionella Conference to Address Emergent Health Crisis