Fees 

Our full 510(k) submission service provides end-to-end regulatory support to help you achieve FDA clearance efficiently and compliantly. We handle the entire process—from predicate device selection and regulatory strategy to preparing and submitting the complete 510(k) dossier in eSTAR or traditional format. Our team ensures all required documentation is accurate and aligned with FDA expectations, including labeling, risk analysis, biocompatibility, software validation, and performance testing. We also manage pre-submission meetings, FDA correspondence, and responses to requests for additional information—delivering a turnkey solution tailored to your device.

Our Traditional 510(k) submission service offers comprehensive regulatory support for Class II medical devices requiring FDA clearance. We manage the full lifecycle of the submission, starting with regulatory strategy and predicate device selection, followed by the preparation of all required sections—including device description, substantial equivalence rationale, labeling, sterilization, biocompatibility, software documentation (if applicable), and performance testing data. Submissions are prepared in full compliance with FDA’s current eSTAR or traditional formatting requirements. We also provide support for pre-submission (Q-sub) meetings, and include one round of FDA deficiency response assistance to ensure a smooth path to market.

Our Special and Abbreviated 510(k) submission services are designed for manufacturers making specific changes to an existing, legally marketed device. For a Special 510(k), we support modifications involving design, labeling, or indications for use, where performance data can be referenced or bridged from the original device. For an Abbreviated 510(k), we leverage recognized consensus standards and FDA guidance documents to streamline the submission process. Our team handles all regulatory strategy, documentation, and formatting in compliance with FDA’s eSTAR or traditional pathways, and ensures alignment with current review expectations to expedite clearance. These pathways are ideal for faster time-to-market with reduced regulatory burden.

Our 510(k) Review & Gap Analysis service provides a detailed evaluation of your existing or draft 510(k) submission against current FDA requirements. We thoroughly assess each section—including device description, substantial equivalence, labeling, biocompatibility, software documentation, and performance testing—to identify deficiencies, inconsistencies, or missing elements. This service is ideal for companies seeking to strengthen an internal draft before submission or for those who have received FDA feedback and need expert guidance on corrective actions. You receive a clear, actionable report outlining required updates, regulatory risks, and strategic recommendations to optimize your chances of a successful and timely clearance.

Our Pre-Submission (Q-Sub) Meeting Preparation service helps you engage with the FDA early to gain critical feedback on your device and regulatory strategy. We guide you through the entire Q-Sub process, including drafting targeted questions, preparing a structured briefing package, and aligning your submission with FDA expectations. Our team also supports meeting logistics, rehearsal sessions, and post-meeting summaries to ensure your interactions with the FDA are clear, professional, and productive. This service is ideal for addressing classification, testing plans, clinical requirements, or novel technologies before a 510(k), De Novo, or IDE submission.

Our Labeling and Instructions for Use (IFU) Review service ensures your device labeling meets all FDA requirements for 510(k) submissions. We evaluate your labels, packaging, user manuals, and IFUs for compliance with 21 CFR Part 801, including device identification, intended use, indications, warnings, and contraindications. We also assess consistency with the 510(k) submission content, predicate labeling, and any applicable FDA guidance. Our review includes detailed recommendations and redlines to help you avoid labeling deficiencies that could delay clearance. This service is critical for ensuring your product’s marketing materials align with FDA regulations and the approved indications for use.

Our Literature and Predicate Device Search service provides the foundational regulatory research needed for a strong 510(k) submission. We conduct a comprehensive analysis of FDA databases, peer-reviewed literature, and publicly available 510(k) summaries to identify suitable predicate devices that support a substantial equivalence claim. Each candidate predicate is evaluated for technological characteristics, intended use, and regulatory history to ensure a defensible and efficient path to clearance. The final deliverable includes a predicate comparison matrix, justification for selection, and recommendations for device positioning—all tailored to align with FDA expectations and minimize the risk of review delays.

Our Biocompatibility Planning and Coordination service ensures your medical device meets FDA’s biocompatibility requirements under ISO 10993-1. We assess your device’s materials, patient contact type, and duration of exposure to determine the appropriate biocompatibility test matrix. Our team develops a tailored testing plan, identifies applicable endpoints, and assists in leveraging existing data where possible to minimize testing costs and timelines. We coordinate directly with accredited testing labs, manage documentation for your 510(k) submission, and prepare justification letters or biological risk assessments when appropriate. This service helps you navigate FDA’s expectations while streamlining compliance and accelerating your device’s path to clearance.

Our U.S. FDA Agent service provides foreign medical device manufacturers with a compliant and reliable point of contact for all FDA communications, as required under 21 CFR Part 807. As your official U.S. Agent, we serve as the intermediary between your company and the FDA for registration, inspection scheduling, regulatory inquiries, and emergency notifications. We ensure your Establishment Registration and device listings are properly maintained and up to date, and we assist with annual renewals and FDA correspondence as needed. This service offers peace of mind, responsive support, and a professional U.S. presence to help you meet FDA regulatory obligations efficiently.

Our Comprehensive Patent Search service provides a thorough analysis of existing patents, published applications, and prior art to assess the novelty and potential patentability of your invention. We search U.S. and international patent databases (USPTO, EPO, WIPO) using advanced search strategies tailored to your technology. The deliverable includes a detailed report outlining relevant references, side-by-side claim comparisons, and risk assessments for potential infringement or overlap. This service helps inventors, startups, and R&D teams make informed decisions on whether to pursue a patent, refine their innovation, or adjust their IP strategy—minimizing risk and optimizing patent success.

Our Complete Patent Search & Filing service offers end-to-end support for securing intellectual property protection. We begin with a comprehensive prior art search across USPTO, EPO, WIPO, and other global databases to assess patentability and identify potential risks. Based on the findings, we provide strategic recommendations and draft a robust utility or design patent application tailored to your invention and commercial goals. Our service includes claim drafting, specification preparation, drawings coordination, and electronic filing with the USPTO. We also manage post-filing correspondence, such as responses to Office Actions, ensuring a smooth prosecution process. This turnkey solution is ideal for startups, innovators, and businesses seeking reliable, high-quality patent protection.