Courses

List of training courses for Regulation/QMS

ISO 13485:2016 Understanding & Internal Audit Training

Awareness Training for ISO 13485:2016 Medical Devices – Quality Management System (QMS)

ISO 9001: 2015 Understanding and Internal Audit Training

Medical Device Single Audit Program (MDSAP) – Compliance Training

Medical Device Regulation (EU) 2012: MDR 2017/745 Compliance Training

List of training courses for Sterilization, Sterile Barrier System and Environmental Control

Sterilization: Awareness Training in ISO 17665:2024

Irradiation Sterilization (Gamma, Electron Beam and X-ray) for Medical Device Manufacturers – ISO 11137 Compliance

ISO 11137-1:2025 Transition, Technical Application & Radiation Sterilization Practical Training and Workshop

ETO Sterilization: Safety and Environmental Compliance in EO Gas Sterilization and Exposure

Cleanroom Classification, Qualification & Validation, and Contamination Control Based on ISO 14644 Standards

Validation, Routine Control, and Maintaining the Effectiveness of Radiation Sterilization (ISO 11137) and Ethylene Oxide Sterilization (ISO 11135)

Ethylene Oxide Sterilization of Medical Devices – ISO 11135:2014 Requirements

Sterile Barrier System Validation: Awareness Training in ISO 11607-1 and ISO 11607-2

Manufacturing Process Validation for Medical Devices

List of training courses for Risk Management

Awareness Training in ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices (1 day)

Training and Workshop of ISO 14971:2019 Medical Devices – Application of Risk Management to Medical Devices (2 days)

List of training courses for ISO 19011 – Guidance of Auditing QMS

Internal Quality Auditing: ISO 19011: 2018 – Guidelines for auditing management systems Training

List of training courses for ISO 14001 – Environmental Management System

ISO 14001:2015 & ISO 45001:2018 (IMS) Internal Audit

ISO 14001:2015 and ISO 45001:2018 – Interpretation & Application

List of training courses for Process Control

Process FMEA (PFMEA) for Medical Device Manufacturing – Risk Analysis and Preventive Control

Effective Root Cause Analysis (RCA) Workshop

AIAG-VDA FMEA (Failure Mode and Effects Analysis)

Advance Product Quality Planning and Production Part Approval Process

Measurement System Analysis

Statistical Process Control

List of training courses for IATF 16949:2016

IATF 16949:2016 Internal Quality Audit

IATF 16949:2016 Interpretation and Implementation