ISO 13485 FDA HOW TO
ISO 13485 FDA UPDATE

TGA - Annual Report or Periodic Safety Update Report? ISO 13485:2016 - Medical Device Quality Management Systems License annual renewal - What changes to report to HC? What does VW mean by annual requalification?Д¬ustomer and Company Specific Requirements

ISO 13485 FDA HOW TO

How to Add Annual Revalidation requirements to Control Plan?ДЄNNUAL FDA Registration - What 510(k) number to use? However, it is important to carefully assess the nature of the change to determine potential ripple effects and what needs to be considered as part of revalidation It may not be necessary to revalidate a process from scratch merely because a given circumstance has changed. The extent of revalidation will depend upon the nature of the changes and how they impact upon different aspects of production that had previously been validated. It is desirable to designate individuals who have the responsibility to review product, process, equipment and personnel changes to determine if and when evalidation is warranted. These may be based upon equipment, process, and product performance observed during the initial validation challenge studies. The quality assurance procedures should establish the circumstances under which revalidation is required. Such tests and methods usually yield specific results which go beyond the mere pass/fail basis, thereby detecting variations within product and process specifications and allowing determination of whether a process is slipping out of control. One way of detecting the kind of changes that should initiate revalidation is the use of tests and methods of analysis which are capable of measuring characteristics which may vary.

A determination of adverse differences in raw material indicates a need to revalidate the process. Furthermore, when a change is made in raw material supplier, the manufacturer should consider subtle, potentially adverse differences in the raw material characteristics. There should be a quality assurance system in place which requires revalidation whenever there are changes in packaging, formulation, equipment, or processes which could impact on product effectiveness or product characteristics, and whenever there are changes in product characteristics.

Iso 13485 fda