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.
The company has regulatory expertise with auditing, implementing, and maintaining all aspects of QMS activities including design, manufacturing, and post-market support. Its team includes former US 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.
NSF’s highly experienced professionals utilise a proven process and strong project management approach to help you become 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
- Corrective and preventive action (CAPA) and complaint management
- Adverse event or vigilance reporting systems
Supplier control programmes
- Supplier evaluation and acceptance
- Supplier audits and corrective action
- Supplier control program development and remediation
Internal and mock audits
- Regulatory readiness audit or inspections
- MDSAP mock audits
Quality systems inspection technique (QSIT) audit
- QMS support
- QMS statistical support
- Quality metrics planning and support
- Quality system process and procedures development, implementation and support