Specialised

medical device design and development

from concept to market

We specialise in medical device design and development for medtech and pharma innovators worldwide. With 100+ projects and a decade of expertise, we turn your concept into a certified, market-ready medical device.

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Trusted by Medtech leaders

End-to-end, plug in at any stage

No matter where you are in the medical device development cycle, you can trust Perdigó Medical to achieve the next milestones seamlessly

Innovation →

We help you transform a clinical need into a clear, actionable product vision. This early stage defines the intended purpose, user profile, and regulatory context—laying the foundation for a robust and compliant development journey.

Concept design →

Our team translates user needs into technical requirements and high-level architecture. This stage includes the first design iterations, early prototypes, and preliminary verification.

Detailed design →

In this phase, the mechanical, electronic, and software designs are refined into what the final device will be. Design for Manufacturing drives the development of advanced prototypes, a production-ready architecture, and the documentation required for formal verification and smooth transfer to manufacturing.

Pilot manufacturing →

We establish partnerships with trusted manufacturers and suppliers that meet defined requirement. Manufacturing instructions, workflows and quality controls are tested to ensure consistent, high-quality output before full industrialisation.

Verification →

Through design verification, software testing, formative usability evaluations, and risk-control checks, we verify that the device meets all defined requirements to ensure the product has been built correctly and performs as intended.

Validation →

In real or simulated clinical workflows, we confirm the device meets user expectations and intended purpose. Usability validation, clinical evaluation (when needed), and risk file review are conducted to ensure the final product is safe, effective, and ready for regulatory submission.

CE marking →

We prepare the technical documentation notified bodies require. MDR-compliant, traceable, and built on the engineering record we have maintained throughout development.

Industrialisation →

we provide continued support to ensure a smooth transition into manufacturing. This includes coordinating the transfer of the device to production through our established partner network

Go-to-market →

We help you with intellectual‑property compliance‑related activities as the product moves toward market introduction and beyond.

Case study: The Blue Box

Perdigó developed The Blue Box’s non-invasive breast cancer screening device, transforming a 3D-printed prototype into a clinical-ready IVD

“Perdigó's expertise in healthcare engineering and product development was crucial to the progress of our device. Their technical knowledge, flexibility, and total dedication were invaluable, and were essential in ensuring the successful development of the device.”

Joan Vieyra, CTO The Blue Box Biomedical Solutions

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Streamline.
De-risk.
Accelerate

We specialise in end-to-end medical device development to help innovators like you launch excellently engineered, compliant devices within reasonable timelines.

Integrated support beyond engineering

IP Strategy

Your medical device innovation is yours, and we help you protect it from the get-go.

1. Identify what’s protectable

To give you a clear view of where your competitive
advantage truly resides.

2. Conduct prior-art research

To ensure your claims are positioned on solid, defensible ground.

3. Define your patent strategy

To seamlessly align the IP with your commercial
objectives and regulatory pathway.

4. Prepare the technical documentation

To support your IP application with robust documentation.

Regulatory strategy

We build a clear, evidence-driven regulatory pathway for your device.

1. Define the regulatory classification and pathway

To give you early clarity on requirements, timelines,
and approval expectations.

2. Map applicable standards and guidance to your device

To identify the technical and safety benchmarks
your device must meet.

3. Plan the evidence and testing strategy

To focus resources on the verification, validation,
and clinical data that truly matter.

4. Establish design controls and documentation structure

To create a compliant, audit-ready design history file that
accelerates review and minimizes rework.

"Perdigo is a great partner for your device development. Their expertise and capacity to adapt to your needs makes them a great choice to work with."

Laura Andrade R&D, Innovation & New Products Associate Director, Insud Pharma

Let's build your medical device from concept to market

If you have an innovative medtech device idea that can make an impact in the healthcare industry, let’s bring it to life together

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No commitment. Just clarity