Medical Device Validation.
… FDA & EU Regulations | Device Classification | Quality System Requirements, … …
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The design, manufacture, processing and use of medical device products, requires an understanding of the various medical device regulatory requirements and international standards that apply to the validation of medical devices during design and processing, e.g. the FDA Validation requirements, the International Standards Organization’s standards related to medical devices and quality systems, e.g. ISO 13485, ISO 14971, etc.
In order to ensure compliance, if involved in developing, processing or placing medical products onto the European market, you will need to understand the current European Medical Device Regulations (MDR’s).
EU & FDA Regulations, Validation during product Development & Manufacture, Risk driven Validation, Medical Device Classification, Good Manufacturing Practices, EU MDR’s, …
You will need to understand the key international regulatory requirements. The approach to Medical Device Classification, the requirements of the current Good Manufacturing Practices (cGMP’s). In order to ensure compliant Validation, you will need to understand and apply the various requirements of a Quality Management System.
Risk identification and estimation is critical to an effective validation activity, as it points to where your efforts need to be applied. The greater the potential or actual risk, the greater the need for validation and the more comprehensive the validation needs to be.
Validation activity needs a validation gap analysis, validation protocols, a validation master plan.
Medical Device Validation. More details …