Investigational Device Exemption (IDE) Application

Submitting an Investigational Device Exemption (IDE) application is a critical step toward conducting clinical trials for new medical devices. At BioBoston Consulting, we provide expert guidance and support throughout the IDE application process, ensuring your submission meets all regulatory requirements, enabling you to bring innovative medical devices to market faster.

Why Choose Bioboston Consulting for your IDE Application?

Medical Device Regulations Expertise

Our team of regulatory experts has extensive experience in preparing andsubmitting IDE applications, ensuring that your device development aligns with FDA requirements. Our strategic advice and regulatory expertise can guide you through the complexities of device trials.

Personalized IDE Strategy for Your Device

We know that every medical device is different. Our customized strategies ensure that your submission addresses the specific features, risks, and benefits of your device, positioning it for approval and successful clinical trials.

Regulatory Compliance Focus

We can assist you manage potential regulatory concerns, mitigate risks, and streamline the application process to accelerate your clinical development timeline.

Timely and Accurate Submissions
Navigating the IDE submission process requires precision and expertise. We work closely with your team to ensure that your application is accurate, complete, and submitted on time, minimizing delays and allowing you to proceed with clinical testing.

Support Services for our IDE Application

Pre-IDE Meeting Preparation

In preparing for pre-IDE meetings with the FDA, which may involve developing meeting strategy, briefing documents and guidance to present a complete package for intended discussions with regulators.

IDE Application Preparation

Full support for your IDE submission, including preclinical package development (animal data), device design and manufacturing information for the FDA and clinical protocols.

Review of Risk Assessment and Safety Data

Conducting thorough reviews of safety and risk assessment data to ensure that your IDE submission includes all necessary information for regulatory review and approval.

Clinical Trial Design/Protocol Development

Helping to create scientifically sound clinical trial protocols which are in line with FDA expectations, making sure that your clinical study design supports your device’s safety and performance.

Regulatory Electronic Submission Services

Responsible for the entire IDE submission process and eCTD (electronic Common Technical Document) formatting following FDA submission guidelines.

FDA Interaction and Support

Responding to FDA inquiries or requests for additional information, keeping you moving through the process and on track for timely IDE approval and clinical trial initiation.

Market Your Medical Device With BioBoston Consulting

The Investigational Device Exemption (IDE) Application services assist medical device companies in submitting successful IDE applications to continue their clinical trial.

Contact Us Today

To discuss further how BioBoston Consulting can assist with your IDE application requirements and contribute to your medical device development, please contact us for a consultation.