5/21/24, 1:50 PM Meeting and Complying With Regulations | NSF

Life Sciences

Meeting and Complying With Regulations

Achieve sustainable and compliant quality management systems with our expert
team of former regulators and technical experts.

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 Privacy - Terms

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5/21/24, 1:50 PM Meeting and Complying With Regulations | NSF

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)

Resources

Navigating New FDA Regulatory Terrain for Laboratory Developed Tests (LDTs)
Article
The U.S. Food and Drug Administration (FDA), has reclassified Laboratory Developed Tests
(LDTs) as medical devices. Critical insights and strategies from leading industry experts on how
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5/21/24, 1:50 PM Meeting and Complying With Regulations | NSF

to navigate the FDA's new LDT regulations.

World Quality Week Q&A With Quality Management Expert Janet Book
Article
NSF celebrates World Quality Week with a special Q&A with quality management expert Janet
Book, Principal Consultant for Medical Device Consulting

Share this Article

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