Creating and Maintaining Technical Files and Design Dossiers

Our Creating and Maintaining Technical Files and Design Dossiers one-day training course is designed to support manufactures by confirming current regulatory requirements of technical documentation.

The aim of the course is to speed the Notified Body certification process and enable manufacturers to sell compliant devices within the European Union. 

On completion of training you will be able to identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers. 

Participants should have experience with or basic knowledge of European Device Directives – 93/42 EEC and 90/385 EEC. 

Who should attend?

  • Regulatory & quality personnel  
  • People new to companies or roles impacted by the IVD Directive  
  • Distributors of IVD’s  
  • Own Brand labellers (OBL)  
  • Start-up companies  
  • R&D personnel  
  • Internal auditors
  • Clinical and Regulatory Affairs Professionals

Learning objectives

  • Confirm the technical documentation requirements as specified in the Directive  
  • Interpret the general requirements of the Directive using relevant and harmonized standards together with various European & GHTF guidance documents for specific products  
  • Define the process enabling the creation and maintenance of compliant technical files and design dossiers  
  • Explain the Notified Body certification process and level of response required to questions and nonconformities raised

Course Benefits

  • Generate technical documentation that support products, ensuring intended safety and performance and meet regulatory requirements
  • Place products on the market in line with your critical launch dates  
  • Reduce costs by streamlining the certification process

Next Steps

  • Introduction to: ISO 13485 training course - Discover ISO 13485, it's importance and the links to the medical device directives. You'll look at comparisons between it's requirements and ISO 9001 and the Food and Drug Administration's Quality System Regulations
  • Lead Auditor: ISO 13485 training course - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
  • Medical Devices Risk Management: ISO 14971 training course - Our ISO 14971 risk management training is an essential element for all medical device manufacturers. You will learn how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle, helping you implement a risk management framework to achieve ongoing compliance.