Validation & Compliance

When it’s time to prove safe, effective use, we bring structure, senior judgement and calm delivery. Our programmes are built around real users, real tasks and realistic environments—then documented to the standard regulators expect.

Summative testing

Regulatory strategy

Human Factors documentation

Ethics review & IRB

MDR remediation and legacy file upgrades

Market acceptance

Speak to an expert

Test with rigour.
Comply with confidence.

Evidence that stands up to scrutiny.

Bringing a medical product to market is complex, costly, and full of unknowns. We help reduce that risk by turning regulatory theory into practical action—so you stay compliant without losing momentum.

A successful submission isn’t just about ticking boxes; it’s about building robust evidence and weaving it into a clear, credible story that regulators can follow with confidence. That’s why we advocate getting involved early—so we can plan strategically, gather the right evidence at the right time, and prevent usability issues long before validation testing.

Speak to an expert

Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.Reece is a highly knowledgeable, passionate, and hard working human factors professional who you will enjoy working with. He brings honesty, creative solutions, rigorous science, and a well-organized approach to all his work. He also keeps end users at the forefront of all project decisions. I’ve had the pleasure of knowing Reece for many years, and I highly recommend him for your human factors needs.

Melissa Lemke

Human Factors SME

How we help you acheive your goals

Validation/Summative testing

Evidence that stands up to scrutiny.

We design and run validation (summative) studies that demonstrate intended users can use the product safely and effectively in the intended environment, with no observed patterns of unacceptable/serious use error. Protocols, moderation and analysis are proportionate to device risk and aligned with FDA/MDR expectations.

Regulatory Strategy

Reduce risk. Accelerate approval.

We build pragmatic HFE strategies that connect formative evidence, risk controls, and labelling to a credible submission narrative. Our team has first‑hand experience with FDA interactions and large‑scale MDR programmes, so we anticipate the questions and shape the plan to answer them.

Human Factors Documentation

Robust, traceable Usability Engineering Files.

We author and remediate the Usability/HFE file so reviewers can follow a clear line from hazards to controls to evidence—covering intended use specifications, post market reviews, UI specifications, validation plans, use related risk analyses, critical task lists and threshold analyses. We also compile the HFE/Usability Engineering File Summary Report for submission in either the US, Europe, or both.

Ethics Reviews & IRB

Ethical approvals, without the friction.

For US studies, we prepare IRB submissions; in the UK and Europe, we prepare and work with ethics committees. We produce consent forms, participant materials and study designs that manage participant risks, streamlining approvals without compromising timelines.

MDR Remediation & Legacy File Upgrades

Bring legacy portfolios up to today’s bar.

We review existing files against IEC 62366‑1/ISO 14971, close usability gaps, and document critical information for safety—ready for audits and submissions. Our team has supported enterprise‑scale MDR remediation across hundreds of product lines.

Market Acceptance

Close the loop—sustain confidence pre and post‑launch.

We run market acceptance trials for marketing teams who need data pre-launch. Post-launch, we train customer service teams to collect data that helps to identify root causes. We review complaint trends and conduct hands-on research to ensure that real‑world data informs ongoing product support and improvements.

How we help

We integrate deep regulatory expertise with practical commercial insight, ensuring your products are not only approved but succeed in the real world.

Human Factors Expertise That Goes Beyond Compliance

Real insight, not generic reports

We don’t dump data on your desk. We help you use it to build something better.

A partner who brings clarity

We’re honest, human, and invested in your success.

Regulatory experience that translates

FDA, MDR, MHRA. We know the nuances and help you prepare for what’s ahead.

Answering your questions

Got more questions? Send us your enquiry below

1. What makes Formara different from other Human Factors consultancies?

We only assign truly senior specialists to your project — people with deep, hands-on experience across usability, risk management and medical device regulations. You won’t be passed to juniors or siloed experts. Our approach is collaborative, flexible, and grounded in real-world project constraints.

2. Do you only work with large companies, or do you support startups too?

We support both. While we regularly partner with leading MedTech and Pharma companies, we also help select startups build strong foundations and navigate early-stage development. Our flexible approach adapts to your size, budget and regulatory pathway.

3. Can you help with both formative and summative (validation) studies?

Yes. We offer end-to-end usability support, from early research and task analysis to validation studies for regulatory submission. We also support instructions for use (IFU) development, risk management files, and more.

4. Do you work internationally?

Yes. We’re based in the UK but frequently support clients across Europe and North America. We conduct in-person and remote research globally, and we’re experienced in aligning with regional regulatory expectations like FDA, MHRA, EU MDR and NMPA.

5. How early should we involve Human Factors in our project?

Ideally, from the beginning — but we can help at any stage. Early involvement maximises impact, helps avoid costly redesigns and ensures that usability and risk are considered proactively, not just reactively.

6. Can you work alongside our internal design or engineering teams?

Absolutely. We integrate closely with your teams, adapting to your workflow and tools. We're used to collaborating with R&D, regulatory, marketing, and more — and we make it easy to work with us.

7. How much does a typical project cost?

It depends on scope, but we’re happy to provide indicative pricing early on. Many formative studies range between £20,000 and £50,000. We also offer flexible day-rate consultancy and embedded resource options. Every proposal is bespoke and ultra transparent.

8. Can you support us with a tight deadline?

Often, yes. Because our team is experienced and lean, we can move quickly when needed. If you’re up against a deadline, reach out and we’ll let you know realistically what’s possible — and how to prioritise.

9. Do you provide facilities and recruit participants for usability studies?

Yes, we can manage the entire study logistics — including participant recruitment, facilities, equipment and moderation. We also offer hybrid and remote options where suitable.

10. Are you familiar with regulatory expectations like FDA guidance or IEC 62366?

Yes. Our team has extensive experience with FDA guidance, and IEC 62366 compliance. We know how to balance regulatory expectations with practical, commercial realities — helping you meet requirements without overcomplicating your process.

Answering your questions

Got more questions? Send us your enquiry below

1. What makes Formara different from other Human Factors consultancies?

2. Do you only work with large companies, or do you support startups too?

3. Can you help with both formative and summative (validation) studies?

4. Do you work internationally?

5. How early should we involve Human Factors in our project?

6. Can you work alongside our internal design or engineering teams?

Absolutely. We integrate closely with your teams, adapting to your workflow and tools. We're used to collaborating with R&D, regulatory, marketing, and more — and we make it easy to work with us.

7. How much does a typical project cost?

8. Can you support us with a tight deadline?

9. Do you provide facilities and recruit participants for usability studies?

Yes, we can manage the entire study logistics — including participant recruitment, facilities, equipment and moderation. We also offer hybrid and remote options where suitable.

10. Are you familiar with regulatory expectations like FDA guidance or IEC 62366?

Answering your questions

Got more questions? Send us your enquiry below

1. What makes Formara different from other Human Factors consultancies?

2. Do you only work with large companies, or do you support startups too?

3. Can you help with both formative and summative (validation) studies?

4. Do you work internationally?

5. How early should we involve Human Factors in our project?

6. Can you work alongside our internal design or engineering teams?

Absolutely. We integrate closely with your teams, adapting to your workflow and tools. We're used to collaborating with R&D, regulatory, marketing, and more — and we make it easy to work with us.

7. How much does a typical project cost?

8. Can you support us with a tight deadline?

9. Do you provide facilities and recruit participants for usability studies?

Yes, we can manage the entire study logistics — including participant recruitment, facilities, equipment and moderation. We also offer hybrid and remote options where suitable.