Design & Development

Where smart design becomes scalable development.

We guide engineering teams through the critical early choices that shape performance, quality, and speed. With a focus on risk reduction and process discipline, we enable consistent builds and predictable paths to market.

4M Hours

Design & development

250+
510K PMA

Device projects completed

75+ Years

Combined CDMO experience

Medical Device & Component Development

Moment in the making.

Early development sets the tone for everything that follows. Our cross-functional engineers move quickly and collaboratively, blending human creativity with deep technical mastery. The result: devices that take shape with clarity, foresight, and manufacturability already built in. Our skilled teams of engineers and scientists design for usability, function, and performance. All products are built for efficient manufacturing.

Custom Electromechanical System Design

We bring your electromechanical concepts to life, designing custom systems that are production-ready and fully integrated.

Subassembly & Component Design

Forj Medical designs parts that are precise, reliable, and production-ready.

Sustaining Engineering & Next-Gen Development

We maintain and enhance your existing devices, addressing reliability, compliance, and new features to enable safer, next-generation products.

Let's build what's next

Process Development & Design for Manufacturability

Processes that survive scale, audits, and variability.

Processes are defined, documented, and standardized to ensure designs scale predictably, survive audits, and perform reliably in production. Early integration of engineering and manufacturing improves yield and accelerates the path from prototype to full-scale manufacturing.

Design for Manufacturability, Automation & Scale

We integrate custom automation to simplify assembly operations, improve process capability, and support faster scale-up.

Man looking through a microscope

Custom Prototyping & Process Development

We help teams move complex device designs forward by engineering prototypes and scalable processes at the same time.

New Product Introduction (NPI)

Our structured New Product Introduction (NPI) process accelerates development while minimizing risk. We keep your product moving fast while retaining the highest quality possible, creating a bridge from development to production.

See our application expertise

Quality & Regulatory

Quality and regulatory alignment from day one.

Uncompromising quality and end-to-end regulatory support from development to production. Our streamlined processes keep projects moving forward, ensuring full regulatory adherence while accelerating timelines.

QMS (Quality Control & Management)

Our strong and well-established Quality Management System meets all medical device requirements and spans design, development, manufacturing, commercialization, and service of medical devices. Our deep expertise, including REACH, RoHS, conflict, origin materials, and International Harmonized Standards, leads to the delivery of superior medical devices.

FDA / ISO Certifications

Intricon global certification
ISO 13485 certified, FDA registered.

Minnetronix, Inc Certified to:
ISO 13485:2016

FDA Establishment Registration
Compliant to:
ISO 14971
IEC 60601
IEC 62304

Regulatory Compliance

Regulatory Compliance & Audit Records

We help our partners navigate FDA-related communications, submissions, and meetings and CE submissions, as well as achieving clearances and approvals, ensuring compliance, and mitigating risk.

  • From DHF creation to support for 510(k), PMA, and CE Mark requirements
  • 11 FDA inspections with No Action Indicated (Minnetronix, Inc.)
  • Knowledgeable about IDE, PMA, and 510(k) guidance and processes
  • Audits and inspections with the FDA and other notified bodies
  • DHF creation to support for 510(k), PMA, and CE Mark requirements

Forj Medical Resources

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