Courses
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Medical Device Safety Risk Management (SRM) - English
Medical device safety risk management per ISO 14971 is a systematic lifecycle process to identify hazards, analyze and evaluate risks, implement controls to achieve acceptable levels, and monitor effectiveness throughout the product's use.
$2,500
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Process Failure Mode and Effects Analysis (PFMEA) - English
Process FMEA is a systematic method for identifying potential failures in manufacturing, assessing their severity, occurrence, and detection difficulty, and then prioritizing corrective actions to prevent product defects and ensure quality.
$2,500
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Medical Device Design Validation - English
Design validation is the process of establishing objective evidence that a medical device meets the user needs and intended uses in the actual or simulated use environment. It answers the fundamental question: "Did we build the right product?"
$2,500
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Medical Device Manufacturing Process Validation - English
The DQS Medical Device Process Validation (PV) course is designed for practitioners seeking to become PV experts, aiming to gain a deep understanding of PV, including its benefits, methods, tools, and challenges.
$2,500
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Medical Device Cybersecurity Risk Management - English
Cybersecurity risk management for medical devices is the systematic process of identifying, analyzing, evaluating, and controlling risks related to cyber attacks, data breaches, and unauthorized access to medical device systems.
$3,500
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Medical Device Usability Engineering and Human Factors- English
UE and HF Engineering apply scientific knowledge of human behavior, capabilities, and limitations to medical device design, ensuring safe, effective, and satisfying use throughout the product lifecycle while optimizing usability.
$2,500