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Bringing in medical device experts from around the world, for the benefit of the industry.

Medical Device Training Courses

Cleanroom and Associate Controlled Environment

Medical Device Single Audit Program (MDSAP)

Design of Experiment

Good Distribution Practice for Medical Devices (GDPMD) Internal Audit

Good Distribution Practice for Medical Devices (GDPMD)

Effective Root Cause Analysis

Medical Device Design Control

Failure Modes, Effects and Criticality Analysis in Medical Device Manufacturing

NCR, CAPA & Complaint Handling

Medical Device Manufacturing Process Validation

US FDA 21 CFR Part 820 – Quality System Regulation

Labelling of Medical Devices (ISO 15223-1:2016) & Medical Device Classification

Software Validation Requirements and Excel Spreadsheet Validation

Test Method Validation

ISO13485:2016 Internal Audit

ISO13485:2016 Quality Management Systems

EU Medical Device Regulations (EU MDR 2017/745)

Risk Management for Medical Devices (EN ISO 14971:2019)

ARISE Plus Malaysia: Workshop on EU Regulation 2017/745 for Medical Devices (EU MDR) for Malaysian SMEs

ARISE Plus Malaysia: Workshop on EU Regulation 2017/745 for Medical Devices (EU MDR) for Malaysian SMEs

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