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FDA Compliance for Medical Device Process |
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FDA Compliance Software Solutions for Medical Devices |
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In the highly competitive Medical Device market, only the most innovative and cost-effective products will survive. Success in this industry requires adherence to applicable FDA regulations (such as 21 CFR 820 and 21 CFR Part 11), and may also involve meeting ISO standard requirements (such as ISO 13485:2003). Rapid product development processes providing responsiveness to changing market demands are key to meeting the demands of this market.
Device Manufacturers are challenged with maintaining a Quality Management Software system that can adapt to the changing market needs, provide tools to shorten product development lifecycles, manage the supply chain, and are compliant with a wide range of regulatory requirements. Having an FDA Compliance Software system to maintain compliance to the variety of regulatory requirements, and adapting to business processes is very important to the medical device industry. |
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Challenges
facing the Medical Device Industry |
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Regulatory Compliance
Manufacturers in the Medical Device industry face the task of meeting all regulatory requirements set forth by the FDA and other regulatory bodies. This issue is a top pressure affecting the industry today. EtQ's FDA Compliance Software solution will ensure compliance to regulations such as ISO 13485:2003 and 21 CFR Part 11 by ensuring that an organization identifies, accesses, and evaluates laws, regulations, and internal regulatory requirements. EtQ also has the ability to submit electronic medical device reports (eMDRs) directly through the FDA's automated gateway. This process, called MedWatch Plus, expedites the process of submitting reports by eliminating the need for faxing, mail, and other manual processes. Reports are submitted electronically and receipt is acknowledged within 6-12 minutes of submission. MedWatch is tied directly into EtQ's Complaint Handling Software and Corrective Action Preventive Action (CAPA) Software workflows and enables two-way integration with the FDA.
Demand for Innovation
The Medical Device field is challenged with the task of offering the most innovative products in order to stay ahead of competition. This aspect of the industry makes change necessary to stay ahead of trends and keep an edge on the competition. Using EtQ's Change Management function, quality is linked throughout the product lifecycle as opposed to just the end product and is tracked at design, production, suppliers, and post-production - providing a real-time quality benchmark at every step of the process. Modules such as Risk Assessment, Supplier Quality Management Software, and Project Control integrate with Change Management to ensure a best-in-class quality solution.
Recall
In the Medical Device industry, recall affects costs for not only the manufacturer but also its customers and the FDA. Thirty to forty percent of all recalls are in the Medical Device industry, creating an urgent need for an effective recall management program. EtQ has responded to the need for an efficient recall process and has developed its Recall Management function to ensure the process is handled diligently and effectively. EtQ's Recall Management process incorporates CAPA to prevent defect reoccurrence, ensures timely reports are submitted to the FDA up until the close of the recall, and ensures the distribution of information to all organizations across the enterprise, among other things.
Contract Manufacturing
As more companies rely on Contract Manufacturers to bring their medical device products to market, it is important that the systems implemented allow for increased visibility downstream. EtQ's FDA Compliance Software provides integration at multiple levels of the process, allowing contract manufacturers to take part in the overall medical device industry, without direct access to the main system. This allows the Contract Manufacturers to fill in their pieces of the process, and provide a seamless Quality Management Software, from start to finish.
Validation
As required by 21 CFR Part 11, a secure environment must be maintained, and the medical device industry must be validated to maintain electronic signature integrity. As a result, validation
services can double, or even triple the cost of a software system. EtQ's
FDA Compliance Software is
designed specifically for the
medical device industry, and our
staff has developed the test scripts
necessary to ease system
validation. Because EtQ's
FDA Compliance Software is
usable right out of the box, and configurations are executed at the server level, the need to extensive validation across the enterprise is less than comparative Quality and FDA Compliance Management Software systems in the market.
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