Your Partner for Rapid Clinical Product Development & Launch
Intune teams become an extension to your teams for the quickest path for IVD or medical device product development, analytical & clinical validation, regulatory approval and launch to your target markets.
Service & Capabilities
Our process starts with a deep understanding of the target user. Then we apply our suite of complementary and integrated IVD services to meet the demanding needs of the consumer-facing home-based OTC and point-of-care diagnostics and wellness devices.
Analytical and Clinical Research
with Full Regulatory Support
A full analytical and clinical research team with regulatory expertise providing the most accelerated path to FDA clearance for your IVD device or test. Our team has achieved multiple FDA authorizations, 510(k) clearances, and CLIA Waiver clearances and we will do the same for your medical device.
Full COVID-19 targeted services for FDA Emergency Use Authorizations (EUA) submissions for Point-of-care (POC) and Over the Counter (OTC) products, as well as de novo and 510(k) submissions
IVD Usability Testing & Human Factors Design
Intune incorporates usability testing and human factors design into the core of every IVD product to ensure they are used safely, integrate smoothly and perform the expected operations while providing the users with a delightful experience.
Helping Clinical Laboratories Comply with the FDA
Requirements for LDTs
De Novo - PMA - 510(k) - Pre-submissions (Pre-Subs)
Are you a clinical laboratory that manufactures and uses laboratory developed tests (LDTs)?
The FDA is enforcing its regulatory requirements for LDTs. The FDA is phasing out its general enforcement discretion approach for LDTs. LDTs would have to comply with the same premarket review and other requirements as other IVDs.
How can we help you comply with the new FDA rule?
We are a service that specializes in helping clinical laboratories comply with the FDA requirements for LDTs. We can help you with:
Notifying the FDA of all the LDTs you manufacture and use
Reporting any adverse events or device malfunctions related to your LDTs
Submitting premarket notifications including de novo, PMA and 510(k) applications
Meeting the quality system and labeling requirements for your LDTs
Keeping up to date with the FDA guidance and policies for LDTs
We have a team of experts who have extensive experience in the field of IVD regulation and LDT development. We can provide you with customized solutions that suit your needs and budget. We can also assist you with any questions or issues that may arise during the compliance process.
We are a service that understands the challenges and opportunities of LDT development and regulation. We know how important LDTs are for advancing medical science and improving patient care. We also know how complex and time-consuming it can be to comply with the FDA requirements for LDTs.
That is why we offer a service that is:
• Reliable: We deliver high-quality results that meet the FDA standards and expectations
• Flexible: We adapt to your specific needs and preferences
• Cost effective: We offer competitive prices and flexible payment options
• Responsive: We communicate with you in a clear and respectful manner
• Supportive: We provide ongoing support and guidance throughout the compliance process
Contact us today!