Medical Device Regulatory Consulting
Trusted by industry leaders
Trusted by industry leaders
In complex, highly regulated industries like MedTech, Delve helps accelerate innovation and avoid costly missteps. We offer:
From design controls to supplier certification, Delve guides the development of medical devices in alignment with FDA requirements and ISO 13485 standards.
We apply rigorous de-risking throughout every project to avoid late-stage setbacks and keep progress on track.
Delve focuses on aligning your organization and workflows with medical device compliance standards and creating full traceability for every decision.
The medical device regulatory consultants at Delve focus on aligning your organization and workflows with medical device compliance standards and creating full traceability for every decision.
Dexcom G6 Continuous Glucose Monitoring device - See case study
Delve’s expertise in user research and design significantly improved our product’s user experience. Delve brings strengths that we don’t have, which is why I’m looking forward to working with them again.
They were really passionate about making something that looked beautiful and behaved in beautiful ways.
The technical innovation in Otoscan combined with unprecedented simplicity makes customization a great experience for our patients and audiologists.
Working with our UX lead, the design team came up with a wonderful visual interface with intuitive designs for certain features. This has helped triple engagement in the platform.
Delve helped us define a patient environment that is a true differentiator for our new company.
How Dexcom turned a complex clinical task into a simple, everyday action—and unlocked mass adoption in the process.
To better serve the needs of people with Type 2 diabetes, BD set out to create a central, digital hub for people to manage all aspects of their care.
A device that is used in the neonatal critical care environment that is designed to reduce device-related workflow.
Delve helped BK Ultrasound bundle its game-changing technology into a widely adopted, easy to use, award-winning medical device.
Delve's foundational research and framing help define your opportunities for innovation.
We help you explore and evaluate concepts with speed, supported by CNC, 3D printing, and integrated design and engineering teams at all of Delve's studio locations.
From contextual inquiry to formative studies and usability testing, we help you meet HFE/UE requirements for Class I, II and III medical devices.
Delve's expertise optimizes product development for scale, reliable production, and supply chain stability.
We align software with hardware design, compliance standards, and user experience across embedded, mobile, and cloud systems.
Delve brings ISO 13485, IEC 62366, and FDA compliance expertise with deep experience in documentation and quality control for medical devices.