Delve | Medical Device Regulatory Compliance

Medical Device Regulatory Consulting

Delve is a product innovation services firm. As an end-to-end product development partner, we combine breakthrough creativity with rigorous de-risking and a deep focus on organizational alignment to help you bring your medical device to market faster, with no requirement missed. Reach out and a member of our team will be in touch.

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End-to-end regulatory consulting for medical devices

In complex, highly regulated industries like MedTech, Delve helps accelerate innovation and avoid costly missteps. We offer:

ISO 13485-certified QMS
Human factors experts involved from day one to minimize project risk
Experience in drug delivery, diagnostics, surgical robotics, and digital health
Digital and physical device development capabilities, including embedded software and cloud system integration

Answer critical questions in medical device development with Delve

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.

Nurse using medical device
Lazurite ArthroFree Wireless Camera - See case study
06_Work_Case_Study_Dexcom_G6_Applicator_G5Comparison (1)

Dexcom G6 Continuous Glucose Monitoring device - See case study

Otometrics Otoscan ear scan
Otometrics Otoscan - See case study
Lazurite ArthroFree Wireless Camera
Lazurite ArthroFree Wireless Camera - See case study
Penumbra REAL™ Immersive System
Penumbra: REAL™ Immersive System - 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.
Vamsee Pamula
Founder and President, Baebies
They were really passionate about making something that looked beautiful and behaved in beautiful ways.
Co-Founder
EO Care
The technical innovation in Otoscan combined with unprecedented simplicity makes customization a great experience for our patients and audiologists.
Lennart Goth & Nils Hampel
Owners of Rhein-Neckar-Akustik, for Natus (formerly Otometrics)
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.
Ed Liebowitz
Digital Diabetes Product Leader
Delve helped us define a patient environment that is a true differentiator for our new company.
Joe Matteo
President

Support compliance across the product development lifecycle

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.

Develop your next medical device with confidence