.png)
Medical devices
Speck Design is a San Jose medical device design consultancy. We work inside your ISO 13485 quality system to take devices from clinical need to cleared product.
Speck is a design and engineering partner, not the manufacturer of record. We work inside your ISO 13485 quality system and FDA 21 CFR 820 design controls and hand over the evidence a submission draws on.
Design inputs, user profiles and use-case maps formatted for your design history file.
Design rationale and review packages, plus usability engineering reports to IEC 62366-1.
Verification support: test plans, DFM reports, tolerance analyses and vendor-ready CAD. Your regulatory team files the 510(k), De Novo or PMA.
Experience across connected medical device systems, from surgical hardware to patient-facing digital tools.
Surgical robotics
Diagnostics + imaging
Diabetes care
Surgical + interventional tools
Wearables
Remote monitoring
Lab + life-science instruments
Connected health
One team for industrial design, human factors, UX, mechanical and electrical engineering and NPI. Usability, cost and regulatory scope get decided together, not handed back to you.
Programs scoped in phases, each with a defined first deliverable.
Senior leads stay on the program from definition through transfer.
Physical device and its software interface designed by one team.
Tell us where your program stands, from early concept to design verification. In a first call we walk through scope, risk and how we would work inside your quality system.
From the Journal
01
Top 100 Medical Device Terms and Acronyms
Plain definitions of the regulatory, engineering and clinical terms that come up in device programs.
02
Deep Dive: What is Human-Centered Design
How human-centered design works in practice, from research and synthesis to testing with real users.
03
How to Choose an Industrial and Product Design Company
What to compare when hiring an industrial design firm: process, team, track record and fit.
