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Medical Device Process Validation Training



Medical device companies need their product to go through the validation process for a degree of assurance before heading to market. Government agencies like the Food & Drug Administration require product quality, device specifications, & manufacturing processes to meet certain acceptance criteria to ensure safety and effectiveness for intended users.

This medical device validation powerpoint & checklist will equip you with the knowledge necessary to feel confident that your medical device meets & exceeds medical device validation requirements. This will also increase patient safety and your company’s overall value in the medical device industry

What is medical device validation?

Validating a medical device is the process of verifying and documenting that a medical device consistently performs according to its intended use and its manufacturing process meets the specified requirements. This will increase the degree of assurance for intended users providing more safety.

Validation vs Verification

Verification is defined as ensuring that the design specifications are providing the intended result requested by the user. Design verification activities often ensure compliance with international standards.

Validation activities include ensuring the device provides the patient or end user with the overall intended use of the device. This is a generalized process often completed with a clinical study or usability study.

Why Is Medical Device Validation important?

Medical device manufacturers will find validation training is essential, as it ensures adherence to regulations, maintains product quality standards, manages risks, optimizes processes, drives continuous improvement, and promotes collaboration. It plays a crucial role in meeting regulatory requirements, ensuring device reliability and safety & minimizing potential hazards. Overall, medical device validation training is a vital component in ensuring the effectiveness, compliance, and overall success of medical devices.

What’s included in the medical device validation training?

Rook Template Validation Training Powerpoint

This powerpoint provides guidance on why, how, what needs to be validated. It gives training on the difference between verification and validation. It will train you to be proficient in IQ, PQ, and OQ.

Rook Template Validation Training Quiz

This quiz is a checklist to ensure you are proficiently trained in the verification and validation process. Test your knowledge for the difference between verification, validation, design validation, process validation, IQ, OQ, PQ.

Rook Template Validation Training Quiz Key

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Let RookQS help with your medical device validation

Going through validation activities can be demanding, especially for larger scale projects. The resource and time requirements can sometimes strain day-to-day operations. Let Rook help take the load off and be hands-on with getting your validation needs met. No matter the size and scope of your project, RookQS can help get your company to a validated state!

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