Medical Device Validation Information & Training …
Information & training presentation on EU & FDA regulation, validation during design & manufacturing, risk driven validation, medical device classification, good manufacturing practice, the new EU MDR’s, …
The design, manufacture, processing and use of medical device products, require 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, namely ISO 13485, ISO 14971, etc.
In order to ensure compliance, when involved in the sale of medical products throughout the European market, you will need to understand requilations such as such the Medical Devices Directive, MDD 93/42/EEC and it’s more recent update the Medical Device Regulations 2017 745.
PresentationEze can provide you with information you need on the various aspects of medical device validation. Just access the information & training presentation online, step through and view the detailed information provided.
The presentation will cover 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.
The informational presentation, then steps through how to implement process validation, covers software validation and details the “life cycle approach to validation”.
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.
Aspects of validation, such as completing a validation gap analysis, planning, documenting and reporting validation protocols, the validation master plan, are all covered in the presentation on Medical Device Validation.
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