PROCEDURE PACKS and SYSTEMS WORKSHOP

Training and Workshops

COURSE STRUCTURE

The training workshop consists of real-world case scenarios, supported by a series of mock-up manufacturer’s declarations made under Section 7.5 and checklists which are based on the requirements of the Australian legislation and Medical Device Regulations.

Training and Workshops

AIM

To build competence in understanding the relevant requirements when making a Declaration under SECTION 7.5 relating to Procedure Packs Medical Devices or Systems.

TOPICS COVERED

  • Types of systems and procedure packs medical devices and how to identify the different types of therapeutic goods packaged together;
  • The significance of Regulation 3.10 and declaration made under 7.5;
  • Documentation required to satisfy the declarations made under 7.5;
  • Requirements for inclusion in the Register;
  • Information required to be held by the manufacturer of the pack;
  • Labelling requirements of the component devices;
  • Requirements of the instruction for use of the individual components;
  • Requirements for manufacturers certification for medical devices higher that Class 1;
  • The necessity to hold component manufacturers Declaration of Conformity’ and
  • Meeting the requirements when the pack is supplied sterile.

DURATION: HALF DAY