We have performed several audits of manufacturers, who either want to assess their FDA or Quality System compliance as part of their risk management process, or who are suddenly faced with an upcoming visit by a regulatory agency, such as the FDA. A gap analysis is generated indicating area's of compliance and potential improvements.
These audits are part of our professional services geared towards manufacturers of medical devices. There are two types of audits, either a so-called "desk-audit" or an "on-site" audit.
This audit reviews existing processes and procedures of an organization with the emphasis on product development and/or manufacturing and examines their compliance with either ISO or QSR (FDA) standards and regulations. The existing policies and procedures are electronically sent to us for review. The output is a report with a gap analysis identifying area's of compliance and non-compliance.
This audit is performed on-site and either can be a quality system or an FDA audit or combined. For a mid size organization (50-150 employees), this process typically takes 2-3 days. Interviews with key personnel as well as inspections is part of this process. These audits are typically performed on the request of a manufacturer who either want to assess their FDA or Quality System compliance as part of their risk management process, or who are suddenly faced with an upcoming visit by a regulatory agency, such as the FDA. In addition, these audits are common prior to a OEM agreement, whereby the reseller/dealer wants to make sure that the product they are about to sell/represent is backed by a quality organization and development process.
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