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Ferro Associates
Expanding Your Reach: Unlocking Success through Collaborative Partnership
Our Services
Regulatory Submissions
We specialize in guiding and assisting you with all aspects of your 510(k) regulatory submission.
- Proper Pathway Identification
- 510(k) Submissions
- Risk Assessments
- Standards Compliance
Pre-submission Engagement with the FDA
Enhance the 510(k)-submission process by proactively engaging with the FDA through strategic pre-submission meetings.
- Meeting planning
- Get Feedback From FDA
- Address Concerns In Advance
Standards Testing and Compliance
Comprehensive and reliable testing throughout the entire testing journey.
- Regulatory Review
- Monitoring Testing Activities
- Addressing Device Challenges
- Pre-Submission Review
Regulatory Submissions
We specialize in guiding and assisting you with all aspects of your 510(k) regulatory
submission.
Our comprehensive range of services includes:
Appropriate Pathway
Identifying the appropriate regulatory pathway and device classification of the medical device.
Substantial Equivalence
Researching predicates that meet the FDA's Substantial Equivalence compliance and taking proactive measures to ensure that it can be effectively defended during the review.
Submission Documentation
Evaluating submission documentation to identify gaps and provide guidance to enhance their quality and comprehensiveness.
Essential Performance
Ensuring the 'Essential Performance' statement accurately represents the essential functionalities and performance characteristics of the device.
Risk Assessment
Reviewing risk assessments, ensuring that all potential risks associated with the device are properly assessed and addressed.
Standards Compliance
Review the device's conformance to essential standards such as IEC 60601-x, ISO 14971, IEC 62304, IEC 62366, ISO 10993-x, and many more.
Processing Submissions
Packaging and submitting the 510(k) documents through the FDA portal.
Prepare Responses
Preparing responses to the FDA during the review cycle to ensure a successful outcome.
Pre-submission Engagement with the FDA
We can enhance the 510(k)-submission process by proactively engaging with the FDA through strategic pre-submission meetings.
Guidance
Our services include expert guidance in planning and facilitating these meetings, allowing the client to obtain valuable feedback from the FDA before the official submission.
Concerns Addressed
This proactive approach empowers the client to address any potential concerns or questions early on, ensuring a more streamlined and successful submission process.
Experience
Our team is experienced in navigating the intricacies of pre-submission meetings and can help make the most of this crucial opportunity for collaboration and feedback with the FDA.
Standards Testing and Compliance
Our established professional relationships with accredited Test Labs, such as Nemko and
Element, enable us to access top-tier facilities for comprehensive and reliable testing. With our
comprehensive expertise and industry connections, we guarantee exceptional support throughout the
entire compliance testing journey.
Our services include:
Research
Conducting extensive research and thoroughly reviewing applicable FDA guidance and recognized consensus standards. This allows us to gain a deep understanding of the regulatory requirements and ensures that your device meets the necessary standards.
Test Monitoring
Planning, budgeting, and managing all device testing and certification activities, including requesting, obtaining and reviewing Test Labs quotes to ensure a smooth and efficient process.
Device Evaluation
Evaluating the device key technologies, identifying potential testing challenges, and developing effective strategies to address them.
Pre-Submission Review
We review final test reports, ensuring they are complete and accurate prior to being submitted to the FDA.
As trusted representatives, we can be the client's eyes at the test house during pre-compliance and official testing, safeguarding your interests and ensuring full compliance with all applicable regulations.