Medical Device GDPR Framework
GDPR Compliance for Medical IoT
Health & Wellness
June 2025 - Ongoing
USA 🇺🇸
Overview
Our client is a healthcare technology company developing swallowable capsule cameras that provide a less invasive alternative to traditional colonoscopy procedures. The device captures video footage of the gastrointestinal tract, which is securely uploaded to the cloud for medical specialists to review and analyse, improving patient comfort while enabling scalable diagnostics.
Operating across Europe and the United States and handling highly sensitive medical data, the company required a robust GDPR compliance framework to support its international growth and maintain regulatory trust. Go Wombat was engaged to evaluate its data protection practices, strengthen compliance, and establish a structured governance system for ongoing security and regulatory alignment.
Services Provided for This Case
Challenge
The client faced a complex regulatory environment due to operations across multiple European jurisdictions and the United States. Managing sensitive medical and diagnostic data required strict compliance with varying data protection laws, particularly GDPR, while also addressing cross-border cloud storage and long-term data retention requirements.
In addition, the company’s hardware-and-cloud ecosystem introduced operational complexity, involving multiple stakeholders such as patients, clinics, physicians, and partners. There was a need to clearly define data controller and processor responsibilities, formalise documentation, and establish a structured governance framework.
The client required a comprehensive GDPR assessment and a practical implementation roadmap to ensure their cloud infrastructure was fully compliant, scalable, and prepared for continued international growth.
Solution
Go Wombat approached the project through a structured, governance-driven methodology aligned with the COBIT framework, enabling a thorough evaluation of the client’s compliance maturity, risk exposure, and data protection processes. We conducted a comprehensive GDPR assessment that analysed existing policies, internal practices, and cross-jurisdictional risks, identifying gaps and prioritising corrective actions.
Our team developed and refined essential legal and operational documentation, including privacy policies, Data Processing Agreements, Data Policy Agreements, and Data License Agreements, ensuring they accurately reflected real operational workflows. We also mapped data flows, clarified controller and processor responsibilities, and established clear accountability structures across stakeholders.
To support long-term compliance, we implemented internal guidelines and governance procedures and provided ongoing DPO-level support through regular reviews, policy monitoring, and proactive updates. As a result, the client gained a structured privacy governance framework capable of securely managing sensitive patient data across multiple jurisdictions while supporting continued growth and regulatory readiness.
Technology stack
Backend:
Frontend:
Other:
Result
As a result of the engagement, the organisation achieved structured GDPR alignment across its core operations, supported by formalised documentation, clearly defined data-processing roles, and strengthened governance practices. This significantly reduced regulatory exposure within EU markets and improved credibility when working with European partners.
Although full multi-jurisdiction compliance remains an ongoing process due to the company’s global footprint, it now operates within a strong and scalable compliance framework. One of the most valuable outcomes was the implementation of an active Data Protection Officer function, enabling continuous monitoring and improvement rather than one-time compliance fixes.
This shift from reactive to proactive data governance has lowered long-term regulatory and reputational risk, while ensuring the organisation is well prepared to scale internationally with confidence.
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Clients & Testimonials
The first success metric is Go Wombat’s ability to stick to the roadmap we’ve built together. They’ve been great at delivering when they said they would deliver. We have a big release planned for the end of this week, and they’re on track. They’ve actually delivered everything already, which has given us more time for additional testing.
What's worked really well for us is to see Go Wombat as an extension of our team and not just as a supplier. The company has become a trusted partner. Their thorough planning and ability to stick to a schedule are notable. Customers can expect a partner that integrates smoothly into existing teams and responds well to constructive feedback.
[The software] is working really well, and the experience for the user is seamless. Internal stakeholders are extremely pleased with Go Wombat's skills, which led to the successful completion of the platform and to an ongoing collaboration. The team is thoughtful, creative, and organized, and their development skills are unmatched.
There are a lot of places where they’ve helped us. We’re good statisticians, and we can program a little bit, but Go Wombat is in a different league. The structure and tuning of the databases were handled by them. It involves millions and millions of calculations that have to happen when a user does something like pulling a slide.
Go Wombat developed a custom cloud-based solution for Frontdesk Nordic, a Telecom PBX provider in Sweden with a total of 60 employees. All of the developers from the very beginning of our collaboration demonstrated a great seriousness and willingness to cooperate as a team. They used Django to create a tool that automates the counting of deals and other tasks.
Vladimir and the rest of the developers have helped us very much in streamlining our systems and bringing in good flows to our customers. They have worked in a good and efficient way, but above all we have been pleased with the communication between our companies and the employees. We have only strong recommendations, when it comes to working with Go Wombat.
We have worked with Go Wombat for a bit more than half a year now, hiring both the full-time services of frontend and backend developers on their team. Our experience has been excellent, the team has been able to solve any architecture dilemmas and helped us achieve our software goals in a shorter timeframe than we had initially planned.
The collaboration has been smooth and we have been able to develop our service further and tackle some difficult technical issues together. I would recommend working with Go Wombat because their main focus is the delivery of software that works and their developers are willing to go the extra mile in terms of creativity to make that happen.
Efficiency, knowledge and responsiveness is what first comes to mind when I think about Go Wombat. I had very good communication with the project manager and the developers had a great understanding of the project. They also kept documentation, so the software maintenance and upgrading have been straightforward.
The project consisted of front-end development, and considering the result I will not hesitate hiring them on further various projects. I am pleased to be able to say that I can recommend Go Wombat, their technical knowledge, creativity, and ability to complete complex tasks helped accelerate the project and move it forward.
We have been using Go Wombat for outsourcing parts of our development for several months now, and it's been a fully positive experience. Our team is satisfied with how the Go Wombat developers communicate, solve issues, and take the initiative whenever the problem is time-sensitive.
The team works fast, they ask the right questions, come up with ideas for solutions, and can work both independently and in closer collaboration. They have become one of the driving forces in the creation of our software and we’ve been very impressed with everything. Definitely recommended.
We have been working together for 5 years already on dozens of various projects. The engineers from Go Wombat are experienced and dedicated, they provide decent support efforts and have a sense of efficiency. They also fuse agility, applications functionality, and new technologies implementation very well.
We've faced a lot of technical challenges during our cooperation on security systems, logistics and traffic management, and data analysis where Go Wombat showed a strong grip over the situation and profound expertise. We know the capability of their team and expect them to do everything on a high level — and they do.
Their engineers are dedicated and reliable, and they deliver at an excellent standard. Go Wombat has delivered efficiently and flexibly alongside internal teams, and the client has transformed the architecture of their custom solution thanks to them. They are flexible to our work methods, communication style, and changing needs.
By having a microservices-based system, the company is now also able to provide high-quality services at a reasonable cost for us. They often take the initiative to suggest improvements in the process and our product, which saves us a lot of time and work. Their engineers are highly engaged with us, our customers, and the product quality.
Go Wombat has been able to both understand our initial concept and create a final system. The product looks fantastic and Go Wombat's design work has been exemplary throughout the project. It is a valuable ongoing partnership largely because the technical experience is a welcome addition to our founding team.
Go Wombat created our first product, and handled everything from design and coding through to hosting. Companies can expect a dedicated and responsive team during their whole project. I fully expected them to put the project on hold for six months, but they never missed a beat. They kept on working. It was miraculous.
We're most impressed with Go Wombat's strong project ownership. We give Go Wombat excellent feedback on their responsiveness, out-of-the-box approach, and problem-solving skills. With their help, we’ve been able to keep our customers happy, so we are more than satisfied with their work.
Go Wombat leverages its expertise to deliver results on time and take full control of the project. I have a lot of happy clients who keep on coming back to us, and they’ve praised Go Wombat’s quick response time, curiosity, and problem-solving skills. The team is also incredibly responsive and very professional.
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