We Didn't Know We Needed to Be a Medical Device” – Our Journey to CE Marking

From Virtual Reality Innovation to Medical Device Compliance: The Story of Pedro Thomaz and Revert

Many healthcare technology startups begin with a simple objective: develop an innovative solution that addresses a real problem.

They focus on technology, product development, customer needs, and demonstrating the value of their solution.

But what happens when they discover that entering the healthcare market also means complying with medical device regulations?

For a small technology company, that discovery can introduce unexpected challenges involving regulatory requirements, documentation, testing, clinical evidence, costs, and timelines.

In this episode of Medical Device Made Easy, Monir El Azzouzi welcomes Pedro Thomaz from Revert, a company developing virtual reality solutions for healthcare.

Pedro shares the journey of a small technology company that moved from developing a VR solution to navigating the European medical device regulatory framework.

The conversation explores the challenges, decisions, external support, and lessons that shaped the company's path toward CE marking.

From a Virtual Reality Idea to a Healthcare Solution

Virtual reality technology offers opportunities to create immersive experiences and explore new applications in healthcare.

But developing a technological solution and bringing a regulated medical device to market are two different challenges.

Pedro takes us back to the beginning of Revert's journey.

How did the original idea emerge? What problem was the company trying to solve? Why did it initially focus on nursing homes?

The discussion explores how the company's early experiences influenced the development of its VR solution and its ambitions within the healthcare sector.

The Unexpected Discovery: We Needed to Become a Medical Device Manufacturer

One of the defining moments in the company's journey came when it began approaching hospitals.

What had started as a technology project now required consideration of medical device regulatory requirements.

For a startup without previous experience in this field, the situation raised several important questions.

Where should we begin?

What requirements apply to our product?

How much will compliance cost?

Do we have the knowledge and resources to manage this process?

The episode explores how Pedro and his team responded to this unexpected challenge and what convinced them to continue.

Understanding Medical Device Regulatory Requirements

Moving into the medical device industry requires companies to develop an understanding of their regulatory responsibilities.

For technology-focused startups, this may involve unfamiliar concepts such as intended purpose, device classification, risk management, clinical evaluation, Technical Documentation, and conformity assessment.

Pedro discusses how the team approached these requirements and what they learned while preparing for compliance.

The conversation also explores the challenges of identifying the necessary activities and deciding which responsibilities could realistically be handled internally.

Why External Regulatory Support Matters

Small companies rarely have unlimited resources or large regulatory departments.

When facing unfamiliar regulatory requirements, working with external specialists can provide valuable support.

Pedro explains how Revert identified an external regulatory partner and why the company decided to seek assistance.

The discussion examines the division of responsibilities between the internal team and external experts.

It also considers an important question for other startups:

Would involving regulatory professionals earlier have made the journey easier?

For companies entering the medical device industry, understanding when to seek external expertise can be an important part of planning.

How Compliance Affects Product Development

Becoming a medical device manufacturer isn't simply about preparing documentation.

Regulatory requirements may influence how a product is designed, developed, tested, and evaluated.

For Revert, the journey raised questions about the technical and clinical evidence needed to support its VR solution.

The episode explores whether the company needed to modify its development approach, perform additional testing, or prepare new documentation.

It also examines the role of healthcare professionals in evaluating the technology and supporting its intended medical applications.

Managing Costs and Workload as a Small Company

Regulatory compliance can introduce significant challenges for startups operating with limited financial and human resources.

Documentation, testing, external expertise, and regulatory activities all require time and investment.

At the same time, the company must continue developing its product, supporting customers, and managing daily business operations.

Pedro shares the challenges of balancing these responsibilities and reflects on the activities that required the greatest effort.

The conversation offers a practical perspective on how small technology companies can approach regulatory work without the resources of a large medical device manufacturer.

The Journey Toward CE Marking and Registration in Portugal

An important milestone in Revert's journey was completing the applicable Class I conformity process and registration activities.

Pedro discusses the final stages of preparing the company and its documentation for the European market.

The episode also explores Revert's experience with INFARMED, the Portuguese competent authority.

Topics include documentation readiness, registration activities, and any questions or challenges encountered during the process.

The experience provides a real-world perspective on the steps a small company may need to navigate before placing its medical device on the market.

CE Marking Is Not the End of Regulatory Compliance

Reaching the market is an important milestone, but it doesn't mean that regulatory responsibilities disappear.

Medical device manufacturers must continue to manage their products throughout their lifecycle.

This includes maintaining appropriate documentation, monitoring product performance, managing feedback, and addressing relevant regulatory obligations.

The conversation explores how Revert approaches ongoing compliance with a small team and what the company learned after entering the market.

CE marking is a milestone in the regulatory journey—not the end of it.

Preparing for Future Growth

As healthcare technology companies grow, their regulatory strategies may also need to evolve.

New applications, changes to intended purpose, additional clinical evidence, and expansion into new markets can introduce further requirements.

Pedro discusses Revert's future ambitions and how the company is considering the regulatory implications of growth.

The episode also explores what a move to a higher medical device classification could mean for a small company and the challenges associated with international expansion.

Lessons for Other Medical Device Startups

Looking back at the entire journey, Pedro reflects on the challenges that were more difficult than expected and the decisions that helped the company move forward.

What would he do differently?

Which mistakes could other startups avoid?

And what advice would he give to a technology company that is just beginning to explore healthcare applications?

These questions are particularly relevant for entrepreneurs who may not yet realize that their product could fall within the scope of medical device regulation.

Discover Revert's Virtual Reality Solutions

Beyond the regulatory journey, the episode also introduces Revert's current activities and virtual reality solutions.

Pedro discusses the company's approach, the healthcare environments it works with, and potential opportunities for collaboration.

Listeners interested in VR applications in healthcare can learn more about the company's technology and the types of partnerships it is seeking.

Final Takeaway: Consider Regulatory Requirements Early

The journey from an innovative technology idea to a regulated medical device can involve challenges that startups don't initially anticipate.

For Revert, developing a virtual reality solution was only part of the story.

Understanding regulatory requirements, finding appropriate external support, preparing documentation, managing resources, and navigating the European market-entry process became essential elements of the company's development.

The experience highlights an important lesson for healthcare technology entrepreneurs:

Don't wait until your product is ready for hospitals to investigate whether it qualifies as a medical device.

Understanding regulatory requirements early can help companies make better development decisions, plan resources, and avoid unnecessary surprises.

🎙️ In this episode of Medical Device Made Easy, Pedro Thomaz from Revert shares the real-world challenges and lessons behind the company's journey toward CE marking.

Because bringing innovation to healthcare requires more than great technology—it also requires a clear path to regulatory compliance.

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com

Who is Pedro Thomaz?

Pedro Thomaz is the founder and CTO of Amplified Creations and the co-founder of RVer, a virtual reality medical device for clinical and care settings. RVer is a Class I device under the EU MDR, registered with Infarmed and in EUDAMED, and it uses real 360° footage, always led by a healthcare professional, to support patients in pain, anxiety, palliative care and cognitive stimulation contexts. It is used today in more than 30 hospitals, care homes and social care institutions in Portugal, with over 50,000 clinical sessions.

Links

RVer website: https://rver.pt/en/

RVer's LinkedIn: https://www.linkedin.com/company/rver-vr/

pedro's LinkedIn: https://www.linkedin.com/in/pedrothomaz

Social Media to follow

Monir El Azzouzi Linkedin: https://linkedin.com/in/melazzouzi

Twitter: https://twitter.com/elazzouzim

https://linkedin.com/in/melazzouzi

Pinterest: https://www.pinterest.com/easymedicaldevice

Instagram: https://www.instagram.com/easymedicaldevice

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