Medical device go-to-market support

Getting a device to market takes more than the decision to sell there. Each market sets its own regulatory route, can require changes to the device, and expects the documentation structured its way. We carry out that engineering and regulatory work, so your device reaches its market on a sound route.

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Trusted by medical device leaders

Your medical device GTM strategy

Beyond the commercial

We handle the technical and regulatory aspect of taking your device to market. We set the route each target market requires, make design changes for new markets when needed, prepare the documentation, and do the technical IP work behind protecting the device as it is now built.

Perdigó medical team

Market entry with Perdigó

Beyond commercialisation, medical device market entry brings together four connected areas of work.

Design adaptation

A market can require changes to the device, whether a different material, a revised component, or an adjustment to meet a local standard. We make the necessary changes and lead their verification and validation, so the device continues to meet its requirements and each change is evidenced.

Documentation for new markets

Expanding to a new market means preparing the file to a second set of regulations and standards. Moving between the EU, US and UK can require restructuring the documentation or producing new evidence. We prepare files for all three regimes and know where their requirements diverge.

Up-to-date technical file

After approval, the file has to stay current. Design changes, new variants, and updated evidence all need the documentation maintained, and our ISO 13485 process keeps that controlled and traceable. This also includes the risk management file.

IP support

The production device often differs from what you filed on early, and changes made for manufacture can be separately patentable. We capture the inventions that emerged in production and produce the technical substance your patent team depends on.

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

Why Perdigó?

Pure medical device

Every engineer here works on medical devices and nothing else. The design change a market demands is made by people who know how a regulated device behaves, what a modification touches, and what has to be re-verified once it is done.

Technical documentation expertise

The technical file is our craft, not an afterthought to the engineering. We prepare and maintain device documentation across the EU, US and UK regimes, and we know where their requirements diverge and what each one expects to see.

Plug in any stage

We take a device on wherever it stands, whether fresh from development or years on the market, and carry the work through to a finished result. Picking up mid-lifecycle is routine, not an exception.

Medical devices are all we do

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

10

Application areas

12

Disciplines

+100

Projects

Clear, streamlined engagement

Working with Perdigó is straightforward by design.

01 Scoping call

We discuss your device, its target markets, and where it stands. There is no commitment at this stage, simply an honest view of whether we are the right fit.

02 Needs assessment meeting

Our engineers review your device, its existing documentation and design history in detail, 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 begin working on the agreed deliverable. You receive regular progress updates and checkpoints where key decisions are agreed together with your team and IP lawyers.

05 Handover and next steps

Our engagement ends with the handover of all deliverables and services. We remain available for further support and advice.

Perdigó's medical device regulatory team

Take your device to market

We get your device ready for the market it is entering and support you through to launch.

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No commitment. Just clarity.

FAQs

1. How do you get a medical device to market?

Getting a medical device to market means completing development and then obtaining regulatory authorisation for each market you sell in. After the device is designed, verified, and validated, the manufacturer compiles its technical documentation, obtains the relevant approval or certification for the target market, registers the device, and manufactures it under a compliant quality system. The steps differ by market, so a device sold in several regions follows a separate route in each.

2. What is included in a medical device go-to-market strategy?

A medical device go-to-market strategy sets out how a device reaches its intended markets. On the technical and regulatory side it covers the regulatory route for each market, any design changes needed to meet local requirements, the technical documentation, and the intellectual property position behind the device. The commercial side, covering pricing, distribution, and reimbursement, is planned separately and sits outside the regulatory work.

3. What approvals does a medical device need to sell in the EU and US?

Different ones. In the EU, a device needs CE marking under Regulation 2017/745, which for most classes requires assessment by a notified body before it can be placed on the market. In the US, it needs FDA authorisation through the pathway matched to its risk class: a 510(k) clearance, a De Novo classification, or premarket approval. The two are separate processes, and authorisation in one does not carry over to the other.

4. What is the difference between CE marking and FDA approval?

CE marking is an EU conformity assessment showing a device meets Regulation 2017/745, verified by a notified body for most classes, which lets it be sold across the EU. FDA approval, or more often FDA clearance, is a US regulator's decision on a single device, most commonly a 510(k) finding of substantial equivalence to an existing device. One is a marking regime run through accredited bodies; the other is a government authorisation.

5. Do you need FDA clearance to sell a medical device in the US?

For most devices, yes, though the exact route depends on risk class. Moderate-risk (Class II) devices usually need 510(k) clearance, high-risk (Class III) devices need premarket approval, and many low-risk (Class I) devices are exempt but still require registration and listing. Selling a device that needs clearance without it is unlawful. A CE mark or approval in another country does not substitute for FDA authorisation.

6. Can you sell the same medical device in the EU, US and UK?

Yes, but each market must be cleared on its own terms. A single device can be sold in all three once it meets each market's requirements: CE marking for the EU, FDA authorisation for the US, and UKCA marking or accepted CE marking for Great Britain. The device itself may also need changes to meet local standards, and the technical documentation is prepared to each market's expectations.

7. What does expanding a medical device into a new market involve?

Expanding into a new market means meeting that market's regulatory requirements for a device already sold elsewhere. This can involve preparing the technical documentation to a new regime, producing evidence the new market demands, adapting the device to local standards, and confirming freedom to operate against patents in force there. How much work is needed depends on how far the new market's rules differ from those the device already meets.

8. Is a CE mark enough to sell a medical device in the UK, or do you need UKCA marking?

A CE mark is currently accepted for the Great Britain market, so UKCA marking is not yet mandatory. CE-marked devices can be sold under transitional arrangements running until June 2028 for devices certified under the old EU Medical Devices Directive, or June 2030 for those certified under the EU Medical Devices Regulation. UKCA is the UK's own mark and its long-term route, so manufacturers selling beyond those dates should plan for it. Every device is registered with the MHRA, whichever mark it carries. Northern Ireland is separate and requires CE marking.