Medical device technical documentation for regulatory submission

Perdigó's expertise cuts cost and time

The complete body of evidence of the device's compliance, safety, and quality

A capable device can stall at the final stage. Notified body queries, FDA deficiency letters, and repeated rework cycles push launch dates back. At Perdigó, technical documentation is prepared by engineers who understand your device.

→ We produce each technical file to the format reviewers expect, with the traceability that demonstrates safety and performance.

→ Our end-to-end development service means coherent, thorough, and compliant documentation.

→ Where documentation already exists, we assess it against the applicable requirements, close the gaps, and bring it to submission standard.

Perdigó medical device engineers working on a device's technical documentation

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

"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

“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

What we produce at Perdigó

Compliant, coherent, and submission-ready

Device description and specification

The device, its variants, its intended purpose, and its classification.

Information supplied with the device

The labelling and instructions for use provided to the user.

Design documentation

The record of how the device is designed.

Safety and performance evidence

The evidence of conformity with the applicable general safety and performance requirements.

Human factors and usability documentation

The usability engineering plan, use-related risk analysis (URRA), formative evaluation reports, and human factors engineering (HFE) file.

Verification evidence

The testing that shows the device meets its design inputs.

Risk management file

The hazards, risk controls, and residual risk, managed to ISO 14971.

Post-market surveillance plan

The plan for monitoring the device once it is on the market.

For the EU, US, and UK

We prepare technical documentation for the three markets our clients most often target. We work to each regime's requirements and know where they diverge, so the documentation is built to satisfy the reviewer it will face.

European Union, EU MDR

Technical documentation to the Annex II and III structure, ready for CE marking and notified body review.

United States, FDA

The evidence organised to the relevant premarket submission, such as a 510(k), for FDA review.

United Kingdom, UKCA

Technical documentation prepared to UK requirements for UKCA marking.

Why Perdigó for your technical documentation?

Prepared by the engineers

The people who prepare your documentation understand the device and the standards it answers to. Claims trace to results because the same expertise stands behind both.

Prepared within a certified QMS

Our Quality Management System is ISO 13485-certified. Your documentation is produced under controlled, auditable processes, with the version control and traceability reviewers expect.

Whether we developed the device or not

If we ran the earlier stages, the documentation is already complete and current when the submission is assembled. If you come to us with the device developed elsewhere, we assess what exists, identify the gaps against the applicable requirements, and produce or remediate what the file needs.

Clear, streamlined engagement

Working with Perdigó is straightforward by design.

01 Scoping call

We discuss your device, where it stands, and your target markets. No commitment, simply an honest view of whether we are the right fit.

02 Needs assessment meeting

Our engineers review the device and any existing documentation in detail, so both teams are aligned before 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 prepare and compile the technical documentation, assess and remediate any existing documents, and keep everything traceable to the engineering record. You receive regular updates and checkpoints.

05 Handover and next steps

You receive submission-ready technical documentation for your target markets and support onward into industrialisation.

Perdigó's medical device regulatory team

FAQs

1. What is medical device technical documentation?

Medical device technical documentation, or formerly technical file, is the complete set of evidence a manufacturer compiles to demonstrate that a device meets the applicable regulatory requirements. Under EU MDR 2017/745, its required content is defined in Annexes II and III. It covers the device description and specification, design and manufacturing information, evidence of safety and performance, risk management, verification and validation results, and post-market surveillance.

2. What is the difference between a technical file and technical documentation?

They describe the same body of evidence, but the two terms come from different regulations. "Technical file" was the term used under the old Medical Device Directive. EU MDR 2017/745 replaced it with "technical documentation" to reflect the broader and more detailed evidence now expected by regulators. In everyday industry use, the two terms are still used interchangeably.

3. What must EU MDR technical documentation include?

Under Annex II of EU MDR 2017/745, technical documentation must include the device description and specification, the information supplied by the manufacturer such as labelling and instructions for use, design and manufacturing information, evidence of conformity with the general safety and performance requirements, the benefit-risk analysis and risk management, and product verification and validation results. Annex III adds the documentation for post-market surveillance.

4. How long must medical device technical documentation be kept?

Under Article 10(8) of EU MDR 2017/745, manufacturers must keep the technical documentation available to competent authorities for at least 10 years after the last device is placed on the market. For implantable devices, the minimum retention period is 15 years. The same periods apply to the EU declaration of conformity and any relevant certificates.

5. What documentation does an FDA 510(k) submission require?

A 510(k) is a premarket submission that demonstrates a device is substantially equivalent to a legally marketed predicate device. It sets out the device description, its intended use, and a direct comparison with the predicate, supported by performance data. Depending on the device, this can include bench testing, biocompatibility, software documentation, and electrical safety and electromagnetic compatibility evidence.

6. What is UKCA marking for medical devices?

UKCA (UK Conformity Assessed) marking is the route to place a medical device on the Great Britain market after conformity assessment against UK requirements, with registration through the MHRA. CE-marked devices are currently still accepted in Great Britain under transitional arrangements, with end dates that vary by device type. The MHRA is reforming the UK regime, so timelines continue to change.

Medical device technical documentation