CONSULTATION SESSION ISO 13485:2016 (MEDICAL DEVICE) QMS IVD UNIT, INFORMM

CONSULTATION SESSION ISO 13485:2016 (MEDICAL DEVICE) QMS IVD UNIT, INFORMM

7th October 2019 - Kubang Kerian, the consultation session for ISO 13485:2016 (Medical Device) QMS was organized by In-Vitro Diagnostic (IVD) Unit, INFORMM Kelantan. The session was consulted by experienced consultant, Dr. Loi Kheng Min from KM Loi Associates Sdn Bhd. The 2-days intensive session was aimed to revise the significant implementation and effectiveness of the international standard requirements and regulations. Activities included are discussion, brainstorming as well as documentation revision for the Surveillance Audit 1/2019 that will be performed by 29th – 30th Ocotber 2019.The session was attended and executed successfully by all members of IVD Unit, INFORMM Kelantan.