All medical devices and software are required to undergo a series of mandatory safety testing in order to satisfy standards such as the FDA Quality System Regulations, the EU’s CE Marking Medical Device Directives, or specific ISO standards. Sterling has extended the experience with various editions of standards and certifications that have become revised over the years have done in-depth research to Part 11 & HIPPA requirements. Gap analysis is generally accredited to being the most proactive and low-cost method in maintaining the efficacy of quality systems. The “gap” aspect is when the comparison of previous standards and ideal future standards are reviewed. The goal is to bridge that gap to turn ideas into a reality. Testing and review must be executed perpetually—not only between updates in editions. Maintaining this integrity throughout operations is especially a habit that should be instilled in new medical device companies that may find themselves with larger gaps. When current standards have just been developed, an intensive research process needs to be undergone to find reliable past resources from outside the company to industry standards.
To effectively complete gap analysis, a number of self-audits and especially third-party audits done from an impartial perspective allows companies to better quantify discrepancies. Considering the current evidence that shows the accuracy of compliance to each requirement, comparisons to where there may be a serious hazard that had been previously overlooked or new standards that can be enhanced are recorded to be addressed following the audit. For specific medical devices in the review, there is a customization of targeted systems, generally such as document control, product planning, and product implementation. Discussions should involve staff members from all departments from business officers, to research staff, to quality and safety personnel, to offer a full picture of company operations from multiple perspectives. Gap analysis can also be supported by the development of comprehensive archival systems through technical and design frameworks, and IT implementations with clear automated or manual comments on why changes are made and feedback on why they need to be addressed consistently which greatly streamlines procedures. Providing consistent reports ensures that documentation will always be available in the case of an FDA warning letter based on allegations that can be swiftly clarified. The formulated feedback encourages consistent improvement in company operation.
September 11, 2020
April 30, 2020
April 29, 2020