Medical Device Validation.

“Easy to follow explanation of validation processes” (J. Matthews. Quality Engineer, Harvard Bioscience Inc.).
“Has really helped me understand the various aspects associated with validation” (A. Jackson, Merit Medical Systems).
“Best explanation I seen yet !” (M. Williams, Paul Hartmann AG).

Medical Device Validation, Regulation, Classification, …

Medical Device Validation, Regulation, Classification, Device Risk. … etc..
880 pages of visual information.
Use to enhance your personal understanding, for personal professional development, as a support in the training of your work peers.
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– FDA Medical Device Regulation & Classification.
– European Medical Device Regulation & Classification.
– Current Good Manufacturing Practices – GMP’s & QSR’s.
– Quality System requirements for effective Validations.
– Process Validation. Protocol development. IQ / OQ / PQ’s.
– Software Validation.
– Design Validation.
– Electronic Signatures & Electronic Records.
– Life Cycle Approach to Validation.
– Revalidation Process Requirements.
– The Validation Master Plan.
– Equipment. Component. Material & Facility Validation.
– Validation and Risk Management.
– Validation Protocol Reporting.
– Validation Gap Analysis.
– The Validation Summary.
– ISO 13485 Focus and expectations of the standard.
– ISO 14971 Objectives of the standard and key areas of focus.
– Medical Device Reporting.
– The Device Master Record.
– The Device History Record.