Successful device commercialization requires continuous engagement with relevant regulatory authorities. Mittal Consulting guides you through compliance with post-approval requirements that ensure safe and effective devices make it to patients.
Mittal Consulting offers a breadth of post-market support, including:
Device Registration and Listing
Navigating the complexities of country-specific registration and listing requirements presents significant challenges for medical device manufacturers. Mittal Consulting simplifies this intricate process for startup and mid-size companies, offering comprehensive support precisely tailored to your regulatory strategy and commercial objectives. From interpreting diverse regulatory frameworks to compiling precise technical documentation, we ensure seamless registration and listing procedures to accelerate market entry and facilitate sustainable global expansion for your innovative medical device portfolio.
Mittal Consulting offers extensive registration and listing services, including:
- Establishment Registration
- License Renewal
- Unique Device Identifier Publication
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Post-Approval Reporting - Annual Reports
Annual reports and summary reports are crucial for maintaining compliance in multiple global markets for cleared medical devices. These mandatory submissions update regulators on device modifications, post-market surveillance findings, and continued safety and effectiveness data. Mittal Consulting provides expert assistance in preparing comprehensive, timely, and accurate reports, helping you meet complex regulatory obligations while freeing up your resources to focus on core business activities.
Mittal Consulting supports a wide array of post-market reporting requirements, including:
- Post-Approval Reports
- Annual Safety Reports
- Post Market Surveillance and Periodic Safety Update Reports
Supplements, Amendments, and Notices
As your product evolves, you may need to notify regulatory authorities of design, manufacturing, and labeling changes. Mittal Consulting manages documentation preparation and submission to support seamless communication with regulatory authorities.
Mittal Consulting offers assistance with an array of post-market regulatory submissions, including:
- Manufacturing Notices
- Panel-Track and Real-Time Review Supplements
- License Amendments and Change Applications
30-Day Manufacturing Notices
Timely submission of 30-day manufacturing notices to inform FDA of manufacturing changes associated with certain devices is essential for maintaining regulatory compliance and product quality. We provide efficient and reliable support in preparing and submitting manufacturing notices, minimizing delays and ensuring seamless communication with regulatory authorities.
New Submission Assessment
In the current regulatory landscape, understanding which product updates require a new marketing submissions across different regulatory jurisdictions is essential in order to continue meeting current user needs. Mittal Consulting provides expert guidance on change planning to ensure the best products are made available to patients.
Mittal Consulting offers various avenues for new submission support, including:
- Strategic change planning based on current regulatory timelines
- Letter to File preparation with high quality change documentation
- Pre-Submission (Q-Submission) facilitation to solicit regulator feedback on future product development
180-Day Notices and Panel-Track Supplements
For more significant changes to your high-risk medical devices in the United States, trust Mittal Consulting to provide comprehensive support in preparing and submitting post-market supplements to ensure continued market access for your innovative devices. We effectively guide the development of and manage your submissions, allowing you to focus on optimizing your device for maximal patient benefit.