20+ years in product design & engineering

Medical device design from concept to production

Medical device design from concept to production

Medical device design from concept to production

ManGo helps medtech teams design, engineer and prototype safe, usable medical devices. From early product strategy to manufacturable design, we work through ISO 9001 and ISO 13485 certified processes.

ManGo helps medtech teams design, engineer and prototype safe, usable medical devices. From early product strategy to manufacturable design, we work through ISO 9001 and ISO 13485 certified processes.

Discuss your medical device project

20+

medical product design experience

ISO

ISO 9001 and ISO 13485 processes

50+

brought from idea to market

Tell us about your medical device project

Share what you are developing, where you are in the process and what challenge you want to solve. We’ll respond within one business day with a practical next step.

No obligation. NDA available before sharing confidential details.

Trusted by

Amsterdam UMC
Unicef
Airbus
HP
Hears
Eneco

Medical device development support from concept to production

Product strategy

Define user needs, technical risks, use environments and the first viable development route.

Industrial design

Create intuitive, ergonomic and professional devices for clinical, patient and consumer-health use.

Engineering

Mechanical design, enclosure development and design documentation for verification, certification and production preparation.

Prototyping & testing

Functional models for usability studies, clinical feedback and design validation.

Manufacturing support

Supplier-ready DFM, production documentation and transfer to manufacturing.

Medical and healthcare product experience

From patient monitoring and diagnostics to clinical tools and connected healthcare products, ManGo combines product design, engineering and production readiness.

Medical Equipment

Industrial design, enclosure engineering and production detailing for clinical environments.

Wearables

Human-centered workflows, ergonomics and device interaction for healthcare settings.

Portable devices

Fast, testable builds that support iteration, verification and stakeholder decisions.

Clinical equipment

Design for cleaning, serviceability, robustness and real-world use conditions.

Usability and handling

Tangible models and ergonomic validation before costly tooling decisions.

Wearable healthcare products

Comfort, performance and manufacturing requirements balanced in one product system.

A structured route from medical idea to market-ready product

We combine strategic product definition, human factors, engineering and supplier-ready documentation in a process that respects regulated development.

01

Define the device strategy

Clarify users, use environments, technical risks and the first viable development path.

02

Design and prototype

Create concepts, ergonomic models and working prototypes that can be tested early.

03

Engineer for verification

Detail mechanics, electronics integration and design documentation for robust validation.

04

Transfer to production

Prepare manufacturable parts, supplier communication and production-ready refinements.

SELECTED MEDICAL PROJECTS

Medical device projects we delivered

Patient monitoring device

Patient monitoring · IMS Medical Severo

From clinical concept to certified monitoring device

ManGo developed the complete industrial design and mechanical engineering of a clinical patient monitoring system. The design addressed strict disinfection requirements, ICU workflows and MDR documentation aligned with class IIa certification.

14 months

concept to production-ready design

Class IIa

MDR-aligned documentation delivered

Wearable diagnostics · Adam Health

Consumer-grade medical wearable from idea to functional prototype

Adam Health needed a compact diagnostic wearable for male health monitoring. ManGo led concept development, industrial design, ergonomics and full engineering of the enclosure — producing a manufacturable design ready for clinical trials and investor presentations.

8 weeks

to first functional prototype

DFM ready

design-for-manufacturing package delivered

Wearable diagnostic prototype

Why medtech teams choose ManGo

ISO 9001 & 13485 certified quality processes

Consistent certification-ready quality at every stage of the project.

Usability engineering and human factors throughout

Human factors assessment and usability testing integrated in the design cycle.

Designed for manufacturing from first concept

Manufacturing constraints are included early to reduce late-stage redesign and tooling risk, with production support through trusted manufacturing partners.

Partner network where needed

For electronics and manufacturing, we coordinate with your existing partners or connect you with trusted specialists from our network.

“ManGo understood the complexity of designing for the clinical environment from day one. They translated our requirements into a device that passed usability testing and is now in production.”

Dr. Robert van der Berg

CEO · IMS Medical Severo

Frequently asked questions

How does your process work from the first meeting?

After your initial request we plan a short intake call (30–60 min) to understand your device, current status and goals. Within one week you receive a tailored project proposal covering scope, timeline and budget.

How long does a medical device design project typically take?

A first functional prototype typically takes 8–16 weeks depending on complexity. A full development trajectory from concept to production-ready design usually takes 12–24 months depending on regulatory class and scope.

Who owns the IP after the project?

All IP generated by ManGo during your project is contractually assigned to you upon completion. We also offer NDA signing before any project discussions begin — we can share our template or sign yours.

Can you support CE marking and MDR compliance?

We design with regulatory intent throughout and produce structured design documentation aligned with MDR and IVD frameworks. We work alongside your regulatory consultant or appointed body — we do not certify devices ourselves.

Do you also help with finding a manufacturer?

Yes. We deliver supplier-ready documentation and can introduce you to our network of ISO-certified contract manufacturers in Europe and Asia. We support the technical transfer so production starts without delays.

Medical device design that moves from concept to market

Medical device design that moves from concept to market

Medical device design that moves from concept to market

We help medtech companies develop safe, usable and manufacturable medical products. Let’s discuss your project.

Request a free consultation

Receive a personal response within one business day.