Medical device manufacturing | Perdigó Medical

Expert support throughout

Our work covers three connected areas:

Manufacturer matching

We start from your device, its specifications, your preferences, and the specifics of your case, then draw a shortlist of manufacturers from our network suited to your device type and production volume. A shortlist built for your device and your volume.

Manufacturer qualification

We assess each candidate against what matters for your device: quality certification, process capability, materials handling, and capacity. Every assessment is documented, so the rationale for the chosen partner is clear and traceable.

Support throughout

As the device moves into production, we advise on materials, specifications, and the practical decisions that arise, keeping each one anchored to what the design requires. Our engineers guide the move; the chosen partner builds.

Trusted by medical device leaders

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

“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

“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 has very strong device development capabilities and experience for inhalation and broader drug delivery medical devices. They are an excellent development partner."

Steven Dudley

Head of Development Invox Pharma

From requirements to manufacture

From the first conversation to stable production, we stay with the process. Here is how the stage runs, and how we are involved at each step.

1. Scoping

We start with a conversation about your device: target volume, timeline, cost expectations, quality requirements, and whether you need a local or foreign manufacturing site.

2. Qualification and shortlisting

We assess manufacturers against your device's requirements and the constraints set at scoping, and draw a shortlist matched to your device and your volume.

3. Quotes and negotiation

We approach the shortlisted manufacturers for quotes or, depending on the industry and the volumes involved, enter negotiation. This covers current and future supply capacity, timelines, and terms, so the chosen partner can deliver now and as your volumes grow.

4. Selection

You select the manufacturer on a clear, recorded basis, with the qualification findings and the commercial terms side by side.

5. Documentation handover

We hand over the manufacturing documentation set: the manufacturing instructions, specifications, bill of materials, etc.

6. Production setup

The manufacturer sets up its process, tooling, and line for your device, and puts its production quality controls in place. We stay available for the engineering questions that come up as the process takes shape.

7. Design adjustments

If setup shows the design needs to change to fit or optimise manufacture, whether a material, a process, or a tolerance, we make the modifications. We update the documentation to match, so the record stays current and the device still meets its validated requirements.

8. First runs

The first units are produced against the set-up process. We remain available for any design support, and confirm the build matches the design.

9. Stabilisation

We remain the point of contact through the first routine runs and confirm production is holding to specification. Once production is stable, we step back.

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

Clear, streamlined engagement

Working with Perdigó is straightforward by design.

01 Scoping call

We discuss your device, where it stands, and your manufacture 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

We discuss in detail your needs, quality requirements, and special specification so both teams are 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

We qualify and shortlist manufacturers, run quotes or negotiation, and support your selection. We stay involved through the manufacture of your devices.

05 Handover and next steps

You have a manufacturer in routine production. We remain available to support your device’s market entry.

Perdigó's medical device regulatory team

FAQs

1. What is medical device manufacturing?

Medical device manufacturing is the process of producing a finished, regulated medical device at commercial scale from a validated design. It covers selecting and qualifying a manufacturer, transferring the manufacturing documentation, setting up and qualifying the production process, and building devices consistently and compliantly to specification. It follows design validation and regulatory submission in the development lifecycle.

2. How do you manufacture a medical device?

A medical device is manufactured in a defined sequence: select and qualify a suitable manufacturer, hand over the manufacturing documentation, set up and qualify the production process, make any design adjustments the process requires, then run and stabilise production. Each step is documented so the finished device matches the validated design and meets regulatory requirements. Many companies use a contract manufacturer (CMO) to build the device.

3. How do you choose a medical device contract manufacturer?

Choosing a medical device contract manufacturer involves assessing candidates against the device's specific requirements: quality certification such as ISO 13485, process and materials capability, capacity at the required volume, supply reliability, and a track record with comparable devices. Document the assessment so the choice is traceable.

4. What documentation is needed to manufacture a medical device?

Manufacturing a medical device requires a controlled documentation set: design drawings, the manufacturing instructions, product specifications, the bill of materials, and the associated quality controls. This record lets the manufacturer build the device consistently and lets the finished product be traced back to the validated design. It must be kept current whenever the production process calls for a design adjustment.

5. What is the difference between pilot manufacturing and full scale manufacturing?

Pilot manufacturing produces a first, low-volume batch of devices for validation and testing, with hands-on engineering support. Full-scale manufacture, also called industrialisation, comes later, often after device certification or approval, and establishes routine production at commercial volume. The two stages can use different manufacturers, because a partner suited to a pilot batch may not fit sustained commercial supply.

Manufacturing your medical device with the right partner

The right manufacturer for your device