We are pleased to extend an invitation to SAMED members to attend a focused and practical workshop designed to support distributors in understanding and implementing ISO 13485 requirements.

The workshop will unpack the regulatory context, clarify distributor responsibilities under ISO 13485, and explore how quality management systems (QMS) directly impact compliance, risk management, and patient safety. Through a panel discussion with SAHPRA-recognized Conformity Assessment Bodies (CABs), members will gain insights into real-world challenges and solutions, with opportunities to ask questions and engage directly with experts.

Who Should Attend

The workshop is tailored to distributors of medical technology. Whether you are just starting out with ISO 13485, preparing for an audit or refining your QMS, this workshop will offer practical insights to help you strengthen compliance and contribute to safer healthcare delivery. It’s designed to meet you where you are and support your next step forward.

Participating SAHPRA-Recognized Conformity Assessment Bodies (CABs)*

• DQS (Pty) Ltd
• JC Auditors
• The Institute of Bio Research Auditing and Training in Southern Africa (IBRATSA)
• KGS Certification Sdn. Bhd
• Sancert (Pty) Ltd
• South African Certification and Auditing Services (SACAS) (Pty) Ltd
• TNV Certification Private Limited (TNV)
• Transpacific Certifications Limited (TCL)

Shape the Discussion – Submit Your Questions

To gain the most valuable benefit from this workshop, we encourage you to submit your questions for the panel ahead of time – this is your opportunity to highlight the specific challenges you face. Your questions will help ensure the discussion is practical and tailored to your needs. All questions are submitted anonymously, so feel free to ask what matters most to you. Submit your questions for the panel here.

 Cost to Attend

• SAMED Ordinary & Associate Members: Free of Charge
• Non-SAMED Members: Please contact alwi@samed.org.za for the cost to attend the event

 Registration

• Click here to register for the event

*All SAHPRA-recognized CABs were invited to participate in this event. More participants may be added as we receive further confirmation of participation.