View all newsletters
Receive our newsletter - data, insights and analysis delivered to you

Quality Management Systems Improvement Consulting

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.

Quality management systems

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

People are generally happy sticking to what they know, to their tried and tested habits as it is easy and painless.
COPQ is increasingly valuable for the pharmaceutical and medical device industries, where maximising product quality is paramount and defect reduction has an additional knock-on effect.
Deciding to use a CMO requires a thorough due diligence exercise conducted both as desktop and on-site reviews.
"Planned" shutdown maintenance is vital for any production facility.
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network