Why Us?
Our Services
Pre-submission Consulting
🔍 Guidance on the Best Regulatory Pathway
Determine if 510(k) or another pathway like De Novo is right for your device, ensuring a smooth regulatory strategy from the start.
Gap Analysis and Readiness Assessment
📊 Identifying Pathways to Compliance
A thorough evaluation of your documentation against FDA requirements to pinpoint gaps and streamline your submission process.
Biocompatibility Assessment
🔬 Ensuring Biological Safety
Navigate biocompatibility testing requirements with expert advice, ensuring your device meets all ISO 10993-1 standards.
Software Validation Support
💻 Compliance for Software-Driven Devices
From software lifecycle management to validation in compliance with FDA guidance, we ensure your device’s software components are fully vetted.
Clinical Evaluation and Clinical Trial Design
📝 Robust Clinical Trial Strategies
Expert support in designing and implementing clinical trials that provide the evidence needed for your 510(k) submission.
Quality System Implementation
⚙️ Quality Management System Excellence
Guidance on implementing a compliant Quality Management System (QMS) in line with 21 CFR Part 820, essential for all 510(k) submissions.
Usability Engineering
👥 Focusing on User Safety and Effectiveness
Design and document usability studies that meet FDA’s human factors requirements, ensuring your device performs safely in real-world scenarios.
Electrical Safety and Performance Testing
⚡ Electrical Safety Assurance
Expert advice on electrical safety and EMC standards and testing, tailored to your device’s specifications and use environments.
Labeling and Promotional Material Review
🏷️ Clear and Compliant Communication
Ensure your labeling and promotional materials meet FDA standards, accurately reflecting your device’s intended use and limitations.
FDA Communication and Submission Management
📞 Your Liaison with the FDA
Manage the entire 510(k) submission process, from preparing your application to responding to FDA queries, with our experienced regulatory professionals.
Post-market Surveillance Planning
🔎 Ongoing Compliance and Improvement
Develop and implement comprehensive post-market surveillance plans, collecting critical data on device performance for continuous improvement.
Each service is backed by our commitment to your success, offering not just solutions but a partnership to navigate the regulatory landscape. Contact Us for a consultation and let us tailor our services to your success.