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Medical Device Audit Readiness

Introduction: 

It is essential that personnel involved in the Medical Device industry have a good foundation in Regulations and Guidelines and the Quality Management System (QMS) and can apply the knowledge to their daily activity.  

Subsequent Notified Body (NB) and /or Regulatory audits/inspections will assess the company's overall conformance and compliance with regulations and guidelines and the "status" of the QMS.  

This training course will cover the following topics to help you prepare for your next Notified Body or Regulatory Authority audit. 

€199 per person Booking

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Medical Device Audit Readiness

Accredited by:Exemplar Global

  • No dates

Topics: 

  • Audit Logistics  

  • Role of Auditors 

  • During the Audit 

  • Audit Facing Do's & Don'ts  

  • FDA Audit Approach Versus EMA Versus Notified Body 

  • Hot Topics and Audit Findings from Regulatory Authorities and Notified Bodies 

  • Lessons Learnt - Post Audit Activities  

 

Who should attend? 

  • All personnel who interact with the QMS 

  • Management and Supervisors 

  • Quality Teams 

  • Internal Auditors  

  • Auditor facing SME’s / Systems Owners 

 

 

This training is delivered by self-paced E-Learning, however IQC also offer traditional classroom-based training should you wish to explore this avenue and / or need a quote for In-house Training email us today [email protected]