Compilation of a Technical File / Design Dossier

This introductory course is of value to employees at all levels within the organisation of Medical Device manufacturers, and suppliers to the Medical Devices industry including:

• Members of The Senior Management Team
• Regulatory Affairs Managers
• Regulatory Affairs Officers
• Quality Assurance Professionals
• Quality Assurance Officers
• Development Engineers
• Operations Managers
• Technical Sales & Marketing Professionals

Course Outline

Putting a Medical Device on the market in any territory requires the manufacturer to compile a file of technical documentation. This training course aims to teach delegates how to construct a file of technical documentation for regulatory submission. Delegates will learn what documentary evidence, and to what level of detail, is required in order to demonstrate a product’s conformity to the essential principles of safety and performance.

In this course we use the ‘STED’ (Summary Technical Documentation) format. This is a format which has been put forward by the Global Harmonisation Task Force (GHTF) which is intended to provide different Regulatory Authorities or Conformity Assessment Bodies with the same documentary evidence that a medical device conforms to the essential principles of safety and performance. The STED format is widely accepted by many Regulatory Authorities and Conformity Assessment Bodies and is recommended by us as a useful format for demonstrating regulatory compliance in one or more world territories.

The STED approach is a consistent and recognised format which can assist regulators in the ease and speed of their reviews which in-turn reduces review time. Therefore resulting in reduced time to market and costs for manufacturers. It also benefits those medical device companies wanting a regulatory submission that is recognised across different key territories.

Our experts will offer delegates advice, guidance and best practice on the detail of information required to assist you through the regulatory submission process.

Topics covered

• Brief Overview of the GHTF
• GHTF guidance including GHTF/SG1/N011:2008 Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
• Purpose and Use of the STED format
  • In the Pre and Post Market Phases
  • Notification of Changes to Regulatory Authorities
• Global Markets that recognise STED including its use for Technical Files & Design Dossiers
• Structure, layout and contents including:
  • Device Description, Product Specification including variants and accessories
  • Labelling
  • Design and Manufacturing Information
  • Essential Principles
  • Risk Analysis and Control
  • Product Verification and Validation
• Declaration of Conformity

Course outcomes

At the end of the seminar, delegates will gain an insight into:

• A knowledge and understanding of the main requirements for Technical Documentation in the STED format
• The ability to compile Technical Documentation in the STED format
• The ability to upgrade existing Technical Documentation, Regulatory Submissions and compile new Regulatory Submission folders to the STED format
• An awareness of those global markets that recognise the use of STED
• An appreciation of the common pitfalls and mistakes within regulatory submissions
• Holiday Inn, Birmingham, UK
• Close to Birmingham International Airport & International train station (with free shuttle bus)
• 1 minute from junction 6 of the M42