Training and Competency Development - Medical Devices

Omnex offers training and competency programs to a wide range of industries, including the medical devices industry. We have designed our training and competency programs to assist organizations in meeting regulatory requirements and enhancing their operations with respect to crucial standards utilized in the medical devices industry. Our programs conver many of the key standards that are commonly used in the medical devices industry, including ISO 13485, ISO 14971, MDSAP, and IEC 62304, and are crafted to equip organizations with the necessary skills and knowledge to comprehend the requirements of these standards and implement them efficiently.

Omnex onsite training and competency services offer a convenient and efficient way to enhance your skills and knowledge. Our expert trainers will provide customized training at your location, saving you time and money. We offer training programs worldwide, including the United States, Mexico, Canada, Europe, and Asia.

ISO 13485:2016 Lead Auditor Training for Medical Devices Quality Management Systems
Register
ISO 13485:2016 Internal Auditor Training for Medical Devices Quality Management Systems
Register
Understanding and Documenting ISO 13485:2016 for Medical Devices Quality Management Systems
Register
Understanding the 21 CFR 820 Quality Management System Regulations (QMSR) and Incorporation with the ISO 13485 QMS
Register
Developing Medical Device Software According to IEC 62304
Register
Lead Auditor Training Based on the International MDSAP Audit Approach
Register
Internal Auditor Training Based on the International MDSAP Audit Approach
Register
Understanding the Requirements of the International MDSAP Audit Approach
Register
ISO 14971:2019 Application of Risk Management to Medical Devices Including DFMEA and PFMEA
Register