Services/Medical Devices
Medical Device Design & Development
SiGenix is a medical device design firm with over 20 years of experience developing FDA-regulated electronics. We design Class II medical device hardware and embedded software under design controls — from first schematic through ISO 14971 risk management, IEC 62304 firmware, IEC 60601-1 safety testing, and 510(k) submission.
From Concept Through FDA Clearance
Medical device development requires more than good engineering — it requires a disciplined quality process. Many contract electronics firms can design a board; far fewer can produce the design history file, risk analysis, and verification evidence the FDA expects to see behind it.
SiGenix has developed medical device electronics since 2005, contributing to cleared respiratory, compression therapy, and patient monitoring devices. Because we do the electronics design, the embedded software, and the regulatory documentation under one roof, nothing gets lost between an engineering decision and the document trail that has to justify it.
What Medical Device Development Includes
Design Controls & Design History File
Development under FDA design controls (21 CFR 820.30) from day one — design inputs, outputs, reviews, and traceability captured in a design history file (DHF) that stands up to audit.
Risk Management per ISO 14971
Hazard analysis, risk assessment, and risk control measures documented per ISO 14971, integrated into design decisions rather than written after the fact.
IEC 62304 Medical Device Software
Embedded firmware developed under an IEC 62304-aligned software lifecycle — software safety classification, architecture documentation, unit and integration testing, and full traceability.
IEC 60601-1 Electrical Safety & EMC
Hardware designed to meet IEC 60601-1 electrical safety requirements — patient isolation, leakage current, means of protection — and IEC 60601-1-2 EMC for medical environments.
Usability Engineering per IEC 62366
Use-related risk analysis, formative evaluations, and human factors documentation to satisfy IEC 62366 and FDA human factors guidance.
Verification & Validation
V&V protocol development and execution — bench testing, software verification, and design validation evidence ready for inclusion in your regulatory submission.
Patented Medical Device Technologies
Engineering That Has Shipped — and Been Patented
Frequently Asked Questions
Do you handle the full FDA 510(k) submission?
Yes. We support clients from device classification and predicate strategy through preparing the 510(k) submission itself — technical documentation, substantial equivalence argument, performance testing, and responses to FDA additional information requests.
What class of medical devices do you develop?
Our experience is primarily with Class II medical devices — respiratory devices, compression therapy systems, and patient monitoring equipment — developed under FDA design controls with 510(k) clearance as the regulatory pathway.
Do you develop both the hardware and the software?
Yes. SiGenix handles the complete electronics development: schematic capture and PCB layout, embedded firmware per IEC 62304, switching power supplies meeting IEC 60601-1 isolation requirements, and EMI/EMC compliance per IEC 60601-1-2.
Can you take over a partially completed medical device design?
Yes. We frequently join projects mid-stream — reviewing the existing design and documentation, closing gaps in the design history file, and carrying the device through verification, validation, and submission.
Building a medical device?
Tell us where your project stands — a napkin sketch, a working prototype, or a stalled submission — and we’ll tell you honestly how we can help.
Contact Us