Specialised
end-to-end medical device development
from concept to market
Specialised
end-to-end medical device development
from concept to market
Pedigo’s multidisciplinary team takes your medical device idea from phase zero to market, minimising friction and maximising results
Trusted by Medtech leaders
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.
"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."
End-to-end, but 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
Innovate
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.
Innovation
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.
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.
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 industrialization.
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.
Post-engineering support
After design transfer, 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, offering follow-up and evaluation of intellectual-property strategy, and supporting compliance-related activities as the product moves toward market introduction.
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
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.
If you have an innovative medtech device idea that can make an impact in the healthcare industry, let’s bring it to life together
