Biostatistics and Data Analysis
Comprehensive FDA IND Submission & Clinical Trial Support
Investigational Device Exemption (IDE)
Navigating the IDE Process with Confidence and Precision
Bringing a medical device to market starts with a strong clinical foundation—and in the U.S., that often begins with an Investigational Device Exemption (IDE). At Bionetwork Consulting, we guide medical device companies through every step of the IDE process, helping you prepare robust submissions, meet FDA expectations, and launch clinical trials with confidence.
Our experts bring deep regulatory, clinical, and quality experience to ensure your device meets all premarket requirements and that your IDE application is strategically structured, scientifically sound, and audit-ready.
Expert Assistance for IND Applications & Trial Approvals
Our Services Include:
Regulatory Pathway Assessment
Determining whether your device qualifies for an IDE and identifying the appropriate regulatory pathway (e.g., PMA vs. 510(k)) to support long-term commercialization goals.
IDE Strategy & Planning
Developing a tailored IDE roadmap, including study design guidance, risk classification, labeling requirements, and compliance with FDA regulations under 21 CFR Part 812.
IDE Submission Preparation
Authoring and assembling all components of the IDE application—including investigational plans, protocols, manufacturing data, risk analyses, informed consent forms, and IRB materials.
FDA Meeting Support (Pre-Sub, Q-Sub, etc.)
Preparing for and facilitating strategic FDA interactions to gather early feedback, address concerns, and streamline IDE approval.
