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Quality, ISO and Auditing

Medical Device Quality Management to ISO 13485

A medical device recall usually traces back to a design input that was never verified or a sterilisation process that was never validated. Delegates work through ISO 13485 as regulators read it: the regulatory requirements that sit alongside it, risk management to ISO 14971 across the product life, design and development controls with the design history file, process validation for sterilisation, sealing and software, supplier controls, traceability and unique device identification, complaint handling, vigilance reporting and recall. The programme also covers how the standard differs from ISO 9001, particularly its weight on documented evidence over continual improvement, and how African regulators such as SAHPRA in South Africa approach device establishments. Delegates leave able to build or tighten a device quality system that holds up under regulatory inspection.

5 day course

Course objectives

  • Explain how ISO 13485 differs from ISO 9001 in intent and documentation
  • Apply ISO 14971 risk management across the device life cycle
  • Plan design and development controls and maintain a design history file
  • Validate special processes such as sterilisation, sealing and software
  • Specify supplier controls proportionate to device risk
  • Implement traceability and unique device identification
  • Manage complaints, vigilance reporting and field safety corrective action
  • Interpret regulatory expectations for device establishments in African markets

Who should attend

  • Quality managers at medical device manufacturers and distributors
  • Regulatory affairs officers
  • Design and development engineers for medical products
  • Production and sterilisation supervisors
  • Hospital procurement staff who assess device suppliers

Course outline

  1. 01The regulatory setting for medical devices
  2. 02ISO 13485 compared with ISO 9001
  3. 03Risk management to ISO 14971
  4. 04Design controls and the design history file
  5. 05Process validation for sterilisation, sealing and software
  6. 06Supplier controls and purchasing
  7. 07Traceability and unique device identification
  8. 08Complaints, vigilance and recall
  9. 09Preparing for regulatory inspection

Scheduled sessions

Scheduled sessions for Medical Device Quality Management to ISO 13485
DatesVenueFormatPriceRegister
16 to 20 November 2026Cape Town, South AfricaClassroomR19,950 per delegate
28 December 2026 to 1 January 2027Pretoria, South AfricaClassroomR19,950 per delegate
4 to 8 January 2027Lusaka, ZambiaClassroomUSD 1,325 per delegate
15 to 19 March 2027OnlineOnlineR8,500 per delegate

Medical Device Quality Management to ISO 13485

From R8,500

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