Medical Device Design Companies: Who Fits Which Device Class

Which medical device design companies fit Class I, Class II and Class III programs, what design controls and ISO 13485 actually cost, and when a general product firm is the wrong call.

August 30, 20263 min read

Written by Konstantin Dolgan, Ph.D., NPDP

Founder & CEO, Product Development Engineer

Published August 30, 2026

Key takeaways

How we evaluated these firmsWhether the firm holds its own ISO 13485 certification, or borrows a client system.
Suntra MedTech (formerly Sunrise Labs) — best for Class II devices with softwareNashua, New Hampshire. ISO 13485 certified, strong on embedded software, instrumentation and connected diagnostics under full design controls.
Key Tech — best for diagnostics and lab instrumentationBaltimore, Maryland. Fluidics, motion control and instrument engineering for diagnostics companies.
StarFish Medical — best for early-stage medtech that needs a full teamVictoria, British Columbia. Design, human factors, regulatory and low-volume manufacturing under one roof for startups.
Delve — best for human-factors-critical devicesMadison, Wisconsin, with the Philadelphia drug-delivery and consumer-health team formerly known as Bresslergroup.

Short answer: if your device is Class III or a Class II with a 510(k) and software, hire a firm that runs a certified ISO 13485 quality system in-house — Suntra MedTech, Key Tech, StarFish Medical, Delve or Nordson MEDICAL.

If you are building a Class I or an exempt wellness product and need form, engineering and manufacturable parts, a general product development firm like LA NPDT is cheaper and faster. Choosing by device class, not by brochure, is the whole decision.

Match the firm to the device class

What you are building	Right kind of firm	Typical program
Class III implant or life-sustaining device	Regulated design house with ISO 13485 and clinical experience	Six to seven figures, multi-year
Class II with 510(k), electronics and software	Medical-specialist firm with in-house QMS and IEC 60601 testing support	250,000 dollars and up
Class II, mechanical only, predicate exists	Medical-capable engineering firm plus a regulatory consultant	75,000 to 250,000 dollars
Class I or 510(k)-exempt device	General product development firm with documentation discipline	15,000 to 80,000 dollars
General wellness or fitness product, no claims	General product design and engineering firm	10,000 to 60,000 dollars

Engineer in gloves measuring a Class I medical device housing with calipers beside design control paperwork and a CAD model — Class I and wellness devices still need dimensional discipline and a documented design history — they just do not need a full ISO 13485 quality system.

What design controls actually add to a project

How we evaluated these firms

Whether the firm holds its own ISO 13485 certification, or borrows a client system.
Cleared devices on the market, not renderings of concepts.
In-house software and electronics, since most Class II devices now carry both.
Whether the same firm can support manufacturing transfer and process validation.
Honest minimum engagement — a firm that takes a 20,000 dollar Class II project is telling you something.

The shortlist

1. Suntra MedTech (formerly Sunrise Labs) — best for Class II devices with software

Nashua, New Hampshire. ISO 13485 certified, strong on embedded software, instrumentation and connected diagnostics under full design controls. Not for you if: you are pre-funding and hoping to spend under six figures.

Website: Suntra MedTech

2. Key Tech — best for diagnostics and lab instrumentation

Baltimore, Maryland. Fluidics, motion control and instrument engineering for diagnostics companies. Not for you if: your product is a simple mechanical Class I device — you will overpay for capability you do not need.

Website: Key Tech

3. StarFish Medical — best for early-stage medtech that needs a full team

Victoria, British Columbia. Design, human factors, regulatory and low-volume manufacturing under one roof for startups. Not for you if: you require a US-domiciled supply chain from day one.

Website: StarFish Medical

4. Delve — best for human-factors-critical devices

Madison, Wisconsin, with the Philadelphia drug-delivery and consumer-health team formerly known as Bresslergroup. Usability research and validation feeding design — valuable where use error is the dominant hazard. Not for you if: budget pressure means you plan to skip formative usability studies.

Website: Delve

5. Nordson Medical — best for components and contract manufacturing scale

Multiple US sites. Design paired with validated high-volume manufacturing for catheters, fluid components and single-use devices. Not for you if: you are one product away from a first prototype.

Website: Nordson MEDICAL

6. Regulatory consultants (not design firms) — best for the paperwork alone

Nationwide. If you already have a working device and a manufacturer, an independent regulatory consultant will assemble your 510(k) for a fraction of a full design program. Not for you if: the device itself is not finished — consultants do not engineer hardware.

7. LA NPDT — best for Class I, exempt and wellness hardware that must be manufacturable

Ruston, Louisiana. Industrial design, mechanical engineering, prototyping and design for manufacturing for Class I devices, 510(k)-exempt products, wellness hardware and clinic accessories — plus documentation your regulatory consultant can build on. Not for you if: your device is Class II or Class III, needs a certified ISO 13485 partner, or requires IEC 60601 testing management. We will point you to the firms above. See our medical device work.

Questions to ask a medical device design firm

Are you ISO 13485 certified yourself, and can I see the certificate and its scope?
Name two devices you designed that received clearance, and what your role was in the submission.
Who writes the design history file — you, me, or a consultant I have to hire separately?
Do you run verification testing in-house, or manage outside labs, and who pays for reruns?
What happens at manufacturing transfer, and have you supported IQ/OQ/PQ before?
Would you decline my project, and under what conditions?

Ready to develop your product?

Get a straight answer

Frequently asked questions

How much does medical device design cost?

Class I and exempt devices commonly run 15,000 to 80,000 dollars for design through manufacturable CAD. A Class II device with a 510(k), electronics and software typically runs 250,000 to 1,000,000 dollars once design controls, verification testing and regulatory work are included. Class III programs are multi-year and multi-million.

Do I need an ISO 13485 design firm?

You need a supplier operating under a compliant quality system when your device requires design controls — practically, any Class II or Class III device. For Class I and exempt devices, good engineering documentation is usually enough, and paying for a certified system adds cost without adding clearance speed.

Can a general product development firm design a medical device?

For Class I, exempt and general wellness products, yes, and usually for less money. For anything that needs a submission, a general firm should either work under your quality system with a regulatory consultant attached, or decline the work. Ask which they intend to do before you sign.

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