SAMED-SALDA Regulatory Forum 8 September 2021

R0.00

In this next forum, we take a look at MedTech Europe’s submission on the South African draft Medical Device Regulations and the accreditation requirements for ISO13485.

  • MedTech Europe submission on the SA draft Medical Device Regulations – Diana Kanecka, Senior Manager International Affairs, Medtech Europe
  • Accreditation requirements for the standard ISO13485 – Mookho Morienyane, Assessment Specialist, SANAS

Category:

Description

In this next forum, we take a look at MedTech Europe’s submission on the South African draft Medical Device Regulations and the accreditation requirements for ISO13485.

  • MedTech Europe submission on the SA draft Medical Device Regulations – Diana Kanecka, Senior Manager International Affairs, Medtech Europe
  • Accreditation requirements for the standard ISO13485 – Mookho Morienyane, Assessment Specialist, SANAS

Who should attend?

Regulatory personnel and those who want to gain a greater understanding of medical technology regulations

Programme

09:00 Welcome and formalities – Madeleine Pearce, SAMED Regulatory Committee Chair

09:05 MedTech Europe submission on the SA draft Medical Device Regulations – Diana Kanecka, Senior Manager International Affairs, Medtech Europe

09:35 Accreditation requirements for the standard ISO13485 – Mookho Morienyane, Assessment Specialist, SANAS

10:30 Close

Speakers

Mookho Morienyane

Assessment Specialist, SANAS With qualifications in Bachelor of Science majoring in Biology & Chemistry and Honours Degree in [...]

Diana Kanecka

Senior Manager International Affairs, MedTech Europe Diana Kanecka is a Senior Manager at the International Affairs team at [...]