Medical device engineering · Rionegro, Colombia

Precision manufacturing,
moved closer to home.

Prototyping, manufacturer introductions and site selection for medical device companies working in Colombia.

Three services, one local partner.

A small engineering team in the Rionegro corridor, close to your parts and your suppliers.

Service 01

Prototyping & Performance Validation

From drawing to a part that passes validation, working under your quality system.

  • Technical review of drawings and test protocols (under NDA)
  • Short-run prototypes with dimensional and first article inspection
  • Performance testing to your protocol, with documented reports
How a prototyping engagement works
Service 02

Subcontract Production

We connect you with local manufacturers and stay involved in the relationship.

  • Introductions to manufacturers matched to your product
  • Support during supplier evaluation and first orders
  • On-site follow-up in Colombia
Service 03

Site Selection

We help you compare and visit sites in the Rionegro–Guarne–Marinilla corridor.

  • Side-by-side comparison of zones and facilities
  • Free trade zone and tax incentive review
  • Site visits with you or on your behalf

How a prototyping engagement works.

A staged, low-risk approach: you see results and documentation at every step before committing to the next.

Stage 01

Technical review

We review your drawings, specifications and test protocols under an NDA, and flag manufacturability and measurement risks up front.

Stage 02

Prototype run

A short run of precision-turned prototypes, produced with our machining partners and inspected dimensionally in full, including first article inspection.

Stage 03

Performance testing

We test to your protocol and deliver a documented report of results, with root cause analysis for any deviation.

Stage 04

Transfer to production

Design-for-manufacturability recommendations so the part can move into repeatable production.

We work under your quality system.

We follow your requirements rather than imposing our own, and we support your supplier qualification process, including audits.

  • Controlled drawings and specifications
  • Material traceability and certificates
  • First article inspection and dimensional reports
  • Documented reports for every test
  • Alignment with ISO 13485 / 21 CFR 820 requirements set by you

What to bring to the first call

  • Drawing or 3D model of the component (under NDA)
  • Critical dimensions and tolerances
  • Material specification
  • Performance test protocol and acceptance criteria
  • Target volumes and timeline

Not everything is needed up front. We can start with what you have.

Who does the work

Two engineers with complementary experience in medical device development, product design and testing.

Eduardo Cortés Gálvez

Process Engineering Lead

Systems engineer with an MS in Applied Physics (Universidad EAFIT). Technical lead on an automated anesthesia assistant with an augmented-reality heads-up display, validated in live operating rooms.

LinkedIn Selected work

Álvaro Gómez

Product Design Engineering Lead

Product design engineer who leads design for manufacturability, prototype development and performance testing. [Add years of experience, key specialties and relevant projects.]

Ready to move?

Start with one conversation.

A focused call about your part or your project. We respond within one business day.

Response within 1 business day
No commitment required for the first call
NDA available before you share drawings
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