Meeting and Complying With Regulations

Achieve sustainable and compliant quality management systems with our expert team of former regulators and technical experts.
A young female engineer repairs a faulty medical device - Developing and Improving Quality Management Systems | NSF

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)

Ready to Begin the Process?

Contact us with questions or to receive a quote.

News and Events

Stethoscope with European Union flag - European Commission to Delay to EU MDR Transition Timelines | NSF

European Commission Proposes Delay to EU MDR Transition Timelines

December 20, 2022

Since the EU MDR came into force in 2017, large parts of the MedTech industry and notified bodies have warned that the capacities of the notified bodies to issue new certificates could become the decisive bottleneck for the implementation of the EU MDR and the EU IVDR. This fear has solidified in the last five years.

NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training

May 19, 2020

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’s Health Sciences Team Joins Fight to Save Lives With More Ventilators

April 23, 2020

NSF’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.