Obtaining FDA’s 510(k) clearance or a premarket approval (PMA) for a medical device is a complex and nerve-wracking process. And that’s just in the United States. If your company wants to sell a device to other countries, in addition to the U.S., the requirements grow exponentially. Med tech firms are increasingly using 510(k) submissions software systems to help ease the burden.
MasterControl Registrations is a complete solution for product registration and 510(k) device submission management that will automate your manual or hybrid processes and track various requirements for every geographic location. It will create transparency for effective monitoring of submission bottlenecks.
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An FDA 510(k) is a type of premarket filing to obtain a clearance (permission) to sell a Class I, II or III medical device in the U.S. that doesn't require a PMA. A 1997 FDA 510(k) guidance explains when a manufacturer should apply for a 510(k) for a change in an existing device. A 2014 510(k) summary guidance addresses premarket notifications.
Over a dozen U.S. federal and state agencies, including divisions of the world's largest and most recognized regulatory agency, use MasterControl. If your company is seeking 510(k) submissions software, here’s how MasterControl Registrations will help you address common challenges:
|Lacks Project Visibility: When you have multiple products that need to be registered in many countries, you could get mired in the minutiae and lose sight of the truly critical deadlines.||Creates Project Visibility: MasterControl provides the tools to give you a micro and a macro view of projects. You can zoom in on requirements per country or zoom out for a global picture of all markets just as easily.|
|Granularity is Overwhelming The variables in requirements increase exponentially with the number of countries at issue and the number of products being registered. Keeping up with the granularity of every registration and re-registration project is overwhelming.||Manages Granularity: Standardized, out-of-the-box templates will simplify every registration regardless of granularity. The solution provides a powerful tool for customizing unique or complex processes into templates.|
|Ineffective Project Management: Managing timelines and tracking requirements for every country is difficult with just a spreadsheet, which doesn't scale to complexities. This could result in missed deadlines.||Effective Project Management: With MasterControl, all artifacts related to registrations will be in one place for more effective document management. Dashboards, checklists, and analytics will show the status of every project.|
|Painstaking Process: Manual compilation of documents from multiple teams using different systems (ERP, PLM) is a painstaking and inefficient process that causes delays in submissions.||Streamlined Process:MasterControl automates manual or hybrid processes and simplifies the process of compiling, reviewing, and approving documents from different sources. Notification of approaching deadlines will be automatic.|
|Ineffective Collaboration: Stakeholders who use disparate systems face communication challenges and lack the agility to respond to regulatory issues in a timely manner.||Facilitates Collaboration: MasterControl Registrations can be integrated with the quality management system or other systems to facilitate collaboration.|
|Inconsistent Filings:Different teams focus on customizing registrations to each market, which may result in inconsistent filings. Submission data are fragmented across multiple systems.||Standardized Tools for Consistent Filings: Templates and checklists based on industry standards will foster consistent filings throughout your organization regardless of location. The solution will provide a platform for a unified approach to submissions.|
Transparency of Product Registration Projects: Tools such as dashboards and analytics will make your project visible to all users.
Standardized Processes: Best-practice templates will standardize your submissions and equip your organization with constant readiness and a head start for every registration.
Effective Milestone Management: Checklists will help ensure that stakeholders will meet their requirements within schedule. Approaching or missed deadlines will become glaring.
Increased Efficiency: Automation of routing, review, and approval of documents will greatly streamline your workflow and increase your efficiency. Tasks will no longer slip through the cracks with automatic task notifications and timeline alerts.
Connectivity: 510(k) submissions and other registration projects scattered across jurisdictions require close collaboration among multiple teams. MasterControl provides the connectivity to facilitate collaboration among your stakeholders, including consultants and vendors.
For more information about MasterControl Registrations and 510(k) Submissions Software Systems, contact a MasterControl representative.