Medical device detailed design

Medical device detailed design is the stage where your design is resolved into an advanced working prototype, across whichever engineering disciplines it requires. We refine your early prototypes into one that works, does what it is intended to do, and can be manufactured at scale, along with the design outputs and documentation that verification and manufacturing depend on.

Talk to an expert See our full process

What is detailed design?

Every design detail finalised, and a manufacturable prototype

This is where design-for-manufacturing decisions determine whether the device can be built repeatably, to cost, and to quality. It is also where the design outputs and documentation that verification and the technical file depend on are generated. Because we develop across the disciplines a device requires, from mechanical and electronic to software, in-house, the product we produce holds together across disciplines.

Functioning, manufacturable, scalable.

Detailed design at Perdigó produces your first working, manufacturable prototype and the documentation that supports it.

Mechanical design and DFM

Refined mechanical design optimised for manufacture and assembly. Tolerances, materials, and processes are chosen for how the device will be built.

Electronics and PCB design

Production-intent electronic design and board layout, integrated with the mechanical and firmware work.

Firmware development

Device firmware developed under IEC 62304 and integrated with the hardware, so the device behaves as intended.

Design for manufacturing (DFM) review

Structured DFM and DFA analysis that removes cost and risk from the design before it reaches a manufacturer.

Risk-informed design

Design decisions are traced to risk controls and feed the risk file, so safety is built into the device rather than checked at the end.

Design outputs and documentation

Specifications, drawings, and the bill of materials, plus the design outputs that populate the design history file or technical file.

Manufacturing-ready device

A device and design package coherent enough that pilot manufacturing and verification proceed without rework.

Detailed design is where most of the risk management work happens.

As the device advances to its final form:

Hazards, failure modes, and use-related risks are analysed in depth, and controls are engineered into it rather than added afterwards.

Risk is assessed using hazard analysis, FMEAs, and other methods as the work demands. The findings drive design changes, so controls are built in and traced through the design outputs and the risk management file under ISO 14971.

Use-related risks are designed out.

Why Teams Choose Perdigó for Detailed Design

Full-device engineering in-house

Mechanical, electronic, and software engineering sit under one roof, so the device is developed as one coherent product, with zero hand-over risks.

Specialists in complex tolerances

Complex devices and those produced at volume depend on precise tolerances. Getting them right is one of our core engineering strengths.

Documentation ready, not reconstructed

The technical file is built as the work happens, so you reach advanced stages and regulatory submission without a documentation scramble.

Trusted by medical device leaders

We have helped medical device innovators turn ideas into market-ready products.

“Perdigó’s mechanical design team showed impressive skills, particularly around tolerance analysis. Our collaboration on Design for Manufacturing and Assembly (DfMA) was very productive as a result.”

Gabe German

Senior mechanical design engineer Phillips Medisize (a Molex company)

“Perdigó's risk management work, engineering documentation and expert advice have supported the successful regulatory submission and approval of the Airway Shield device."

Julio M. Alonso

CEO and Chief Medical Officer, Airway Medical Innovations

"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

Clear, streamlined engagement

Working with Perdigó is straightforward by design.

01 Scoping call

We discuss your current status, your needs, and objectives. There is no commitment at this stage, simply an honest view of whether we are the right fit.

02 Needs assessment meeting

Our medical device experts assess your development needs and requirements in detail, ensuring that both teams are fully aligned before any work begins. An NDA is signed around this point.

03 Proposal

You receive a clear proposal that defines the engagement scope, deliverables, timeline, and investment.

04 Kick-off and collaboration

Our team develops the advanced device across all disciplines and produces the documentation. You receive progress updates, with regular checkpoints where we shape direction together and agree the key decisions.

05 Handover and next steps

You receive the manufacturable device, the design outputs, and the documentation, along with a recommended path forward into verification.

Perdigó's medical device regulatory team

Medical devices are all we do

Behind these numbers is a decade of specialised medical device development, concept to submission.

Application areas

Disciplines

+100

Projects

FAQs

1. What is design for manufacturing (DFM)?

Design for manufacturing is the practice of shaping a design around how it will be produced and assembled. It selects tolerances, materials, and processes a manufacturer can hold consistently, reducing cost and risk before production begins.

2. What does the detailed design stage produce?

By the end of the detailed design stage, you receive advanced medical device prototypes built to the production-intent design, and the design outputs and documentation, including specifications, drawings, the bill of materials, and risk records, that populate the design history file or technical file.

3. Is device firmware developed during detailed design?

Yes. Where a device includes software, firmware is developed under IEC 62304 and integrated with the hardware during this stage, so the device behaves as intended and the software record is ready for verification.

4. What comes after detailed design in medical device development?

The device moves into pilot manufacturing, where a first compliant batch is built, and into verification, where it is tested against its design inputs.