Delve | Medical Device Software

Medical Device Software Development

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 embedded, cloud, and mobile medical device software to market faster, with no requirement missed.

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Bring your medical device software to market

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

ISO 13485-certified QMS and software development process conformant to IEC 62304
Digital and physical device development capabilities, including embedded software and cloud system integration
Deep expertise in drug delivery, diagnostics, surgical robotics, and digital health platforms
Human factors experts involved from day one to minimize project risk

Answer critical questions in medical device software development with Delve

Delve designs digital and physical elements in sync with user workflows, ensuring seamless communication between embedded firmware, apps, cloud platforms, and devices.

We design and engineer software for reliability, redundancy, and patient safety. Delve validates feasibility and usability through early user research, prototyping, and human factors testing.

Our product development process aligns risk management, design controls, relevant standards, and stakeholder input from the start to help you get to market faster, with no requirement missed.

We embed regulatory, design for manufacturability, quality assurance, cyber security, and clinical user requirements into every phase of the product development process.

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BD Diabetes Care - See case study
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Dexcom G6 Continuous Glucose Monitoring device - See case study

Otometrics Otoscan ear scan
Otometrics Otoscan - See case study
HDM-Breas IoT Ventilator Platform
HDM-Breas IoT Ventilator Platform - 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 software integration across the product development lifecycle 

Ensure optimal device control, safety systems, and connectivity protocols in embedded software for medical devices.

Delve’s software engineering expertise balances user, regulatory, and security needs in mobile, tablet, or desktop apps for clinicians and patients.

Delve helps implement HIPAA-compliant infrastructure, AI/ML enablement, and device management platforms.

We align software with hardware design, compliance standards, and user workflows 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 medical device software with confidence