FDA Regulatory Compliance Software for Medical Devices

Success in the Medical Device industry requires adherence to applicable FDA regulations - ISO 13485, ISO 14791, 21 CFR 820 and 21 CFR Part 11. 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 Quality and FDA Compliance Management systems 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 with the variety of regulatory requirements, and adapting to business processes is very important to the medical device industry.

Challenges Facing the Medical Device Industry

Electronic Submissions to the FDA

The FDA receives upwards of 400,000 medical device reports annually. In order to give each of these events the individual attention necessary to mitigate risk, the FDA must be properly informed by an organization of all reportable adverse events. Electronic reporting is key to ensuring proper collaboration. EtQ has the ability to submit electronic medical device reports (eMDRs) directly through the FDA's automated gateway. This process 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. EtQ eMDR is tied directly into EtQ's Complaint Handling Software and CAPA Software workflows and enables two-way integration with the FDA.

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 for extensive validation across the enterprise is less than comparative Quality Management and FDA Compliance Management Software systems in the market.

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 and 21 CFR Part 11 by ensuring that an organization identifies, accesses, and evaluates laws, regulations, and internal regulatory requirements.

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 Rating, and Project Control integrate with Change Management to ensure a best-in-class quality solution.

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 and FDA Compliance Management System, from start to finish.

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