Notified Body Audit Support
Situation
A mid-sized medical device manufacturer faced mounting pressure as their critical Notified Body audit approached. The CEO expressed concerns following their previous audit experience, marked by documentation gaps, team confusion during auditor interviews, and difficulty interpreting regulatory requirements.
With limited internal quality resources and a complex regulatory landscape, leadership recognized they needed expert guidance to avoid repeating past mistakes.
Successes
Through systematic gap analysis and mock audit simulations, Veranex identified critical documentation deficiencies and trained key personnel on effective auditor interaction techniques. Our team guided the remediation of all identified gaps, established robust document control processes, and conducted intensive coaching sessions. The result: the company achieved a successful NB audit with zero major non-conformities and ensured they are well-prepared for other future audits.Services by Veranex
- Comprehensive Gap Assessment
- Documentation Remediation
- Mock Notified Body Audit
- Team Training & Coaching
Quality Management Systems
Process Validation Services
Process Validation Services
First-pass process validation success for any manufacturing, sterilization, or packaging process.
Scalable Manufacturing Solutions
Scalable Manufacturing Solutions
Our manufacturing team can support supply chain logistics as well as prototype builds through controlled builds for product launch.
Regulatory Consulting Services
Regulatory Consulting Services
Ensure your plan from concept-to-commercialization is defined for regulatory success.
