Meeting and Complying With Regulations

NSF 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)