Quality Management Systems Improvement Consulting

  • Overview
  • Services
  • Experts
  • Why Work With NSF?

Medical device companies need quality management systems (QMS) that comply with an array of complex and demanding regulatory requirements. NSF has extensive medical device experience in all therapeutic areas including in vitro diagnostics, lab developed tests and combination products. We have regulatory expertise with auditing, implementing and maintaining all aspects of QMS activities including design, manufacturing and postmarket support. Our team includes former U.S. FDA, EU notified body, Japanese Pharmaceuticals and Medical Devices Agency and Health Canada/CMDCAS professionals with strong technical expertise to help ensure your quality systems can comply with the toughest regulatory scrutiny.

Services

Our highly experienced professionals utilize a proven process and strong project management approach to help you become FDA audit ready, manage risks and implement sustainable activities in the areas of:

Quality Systems Implementation

  • Reengineering and process improvement
  • Software evaluation and development
  • Project management

Medical Device Design and Development

  • Design verification and validation
  • Design history file review/remediation
  • Process and test method validation

Risk Management

  • Failure modes and effects analysis, root cause analysis, benefit and risk evaluations, etc.
  • CAPA and complaint management
  • Adverse event or vigilance reporting systems

Supplier Control Programs

  • Supplier evaluation and acceptance
  • Supplier audits and corrective action
  • Supplier control program development and remediation

Internal and Mock Audits

  • Regulatory readiness audit or inspections
  • QSIT audit

QMS Support

  • QMS statistical support
  • Quality metrics planning and support
  • Quality system process and procedures development, implementation and support

Experts

Our staff includes former FDA and EU officials and industry experts who combine global regulatory knowledge with industry best practices to help our clients achieve sustainable and compliant quality systems.

Why Work With NSF?

At NSF, we are committed to protecting patient health and safety. We provide the necessary assurance that your quality management systems comply with international regulatory requirements and allow you to provide safe and effective products on the market.

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