PRODUCT DEVELOPMENT SERVICES FOR MEDICAL DEVICE INNOVATORS

Make your medtech innovation a reality.

As medical device development experts, we help clients create drug delivery, diagnostic, surgical, and home health medical devices. Need to achieve technical, clinical, regulatory, and manufacturing milestones? We leverage an ISO 13485 certified medical device development process to help you achieve your medtech milestones and bring your innovation to life.

WHAT WE DO

100% FOCUSED ON MEDTECH

Expertise + Proven Process

Archimedic is a contract product development firm that is 100% focused on helping clients develop life-changing medical devices. Our expertise spans drug delivery devices, in-vitro diagnostics, surgical instrumentation, and home health products.

Our medtech team offers experience and capabilities in human factors, electromechanical engineering, quality and regulatory management, industrial design, prototyping, design for manufacturability and assembly (DFMA), and production launch.

We are ISO 13485 certified, a credential that ensures our clients reliability in our deliverables and documentation. In addition to providing extensive design and development services, we support the regulatory filings of our clients with robust design history files (DHFs) and device master records (DMRs).

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100% FOCUSED ON MEDTECH

Expertise and support at every step

Our team of medtech experts support you at every stage of the development process. We help you create new intellectual property, build prototypes, conduct V&V, create the DHF, achieve regulatory clearance, and launch manufacturing.

Drug Delivery Devices

In-Vitro Diagnostics

Surgical Instrumentation

Home Health Products

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IT STARTS WITH A CONVERSATION

How to get started

How do you know if we’re a fit for you and your organization? It begins with a free 30 minute conversation. Here’s what to expect from your initial meetings with us.

GET STARTED

ISO 13485 CERTIFIED MEDICAL DEVICE DEVELOPMENT PROCESS

A proven and effective process

Whether you are at the beginning stages of developing an idea or at the point of launching manufacturing, our proven and effective process can help you reduce risk and build value. Click the button below to learn how we fast-track the delivery of medtech milestones.

PHASE 1

Concept Design & Prototyping

PHASE 2

Detailed Development & EVT

PHASE 3

Verification & Validation Phase

PHASE 4

Design Transfer & Scale-Up

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OUR PROCESS, REVEALED

Learn about our ISO 13485 process

We created a video series to share our proven and effective medical device development process. Click button below to learn about our process and fast-track your development program.

WATCH VIDEO SERIES

CTO, PERICOR

Justin Opferman, PhD

"There is no company I trust more than Archimedic to navigate PeriCor through product development and commercialization."

DIRECTOR, FDA PPDC

Robert Levy, MD

"I have seen Archimedic help early-stage pediatric medical device ideas come to fruition. They have all the expertise, experience, and tools to make this happen."

CEO, TANGO

Wamis Singhatat

"Archimedic has been a very capable and long-standing design partner of ours, from the MVP that allowed us to establish initial product-market viability to the mass-manufacturable design for commercialization. "