Contract
Manufacturing

Tailored for startups and growth-stage companies, our contract manufacturing expertise spans from verification & pilot builds to large-scale production, offering seamless scalability and dedicated support.

ISO 13485 Certified

FDA Registered Facility

Class 7 Clean Room

Manufacturing Capabilities

Process Development

Process Validation

Supply Chain Management

Metrology

Device Assembly

Ultrasonic Welding

Laser Welding

Soldering

Laser Marking / Etching

3D Printing

UV Curing / Adhesive Bonding

Sterile Pouch Sealing

Kitting & Secondary Packaging

Device Labeling

Thermoform Tray Sealing

Sterilization Coordination

Don't see what you need listed here?

Not every capability we offer is listed here, and our solutions are continually expanding. Schedule a consultation to discuss your needs and discover how we can help.

Why teams choose Ontogen for contract manufacturing

Built for startups AND scale
(pilot → production without switching vendors)
‍
Design + manufacturing under one roof
(faster iteration, fewer handoffs)
‍
ISO 13485 certified quality system
(regulatory-ready from day one)
‍
Flexible production volumes (10 to 10,000+ units)

Mission Image

Need to make a CM change?

Real quotes we've heard after working with the wrong partner:

"they are...sadly impossible."

"things that should take 1 hr end up taking them 100..."

"it's just been a disaster..."

It's never too early or too late to make a change! Schedule a consultation today to find out how quick and seamless the transition to Ontogen can be.

Take the next step to success

Medical device development can be daunting-- we are here to help.

Schedule A Free Consultation