Q&A

DR compliance requires clinical evaluation, technical documentation, a quality management system, post-market surveillance, and in most cases a Notified Body audit. It's one of the most demanding regulatory frameworks in the world. Thaumatec has hands-on experience navigating these requirements and can help you build a compliant product from the ground up.

You'll need technical documentation, risk management files, clinical evaluation reports, software lifecycle documentation (IEC 62304), a quality management system, and post-market surveillance plans. The exact set depends on your device class and target market. Thaumatec helps clients prepare and maintain all of it as part of the development process.

Meeting FDA and MDR requirements means following structured development processes, maintaining full traceability, producing the right documentation, and working within a certified quality management system. Thaumatec builds compliance into the development process from day one, so you're not scrambling to meet regulations at the end of your project.

FDA approval requires demonstrating that your device is safe and effective through clinical data, technical documentation, software validation, risk management, and a quality management system aligned with 21 CFR Part 820. The process varies depending on your device class. Thaumatec has experience building FDA-ready software.

ISO certification requires building a full quality management system, documenting processes, passing internal and external audits, and maintaining compliance on an ongoing basis. It's a long and complex road, but Thaumatec has already been through it and can guide you through the requirements so you don't have to figure it out alone.

Medical device software must follow strict regulatory standards like IEC 62304, requires full traceability, risk management, and detailed documentation at every stage of development. A bug isn't just a bug — it can be a patient safety issue. Thaumatec specializes exclusively in this space, so compliance and quality are built into their development process by default.

Through a certified quality management system, rigorous testing, risk management processes, and full traceability from requirements to code. Thaumatec holds ISO 13485, ISO 9001, and ISO 27001 certifications and applies these standards across every project, not just at the end but throughout the entire development lifecycle.

Connected medical devices require expertise across the full stack, from firmware and embedded software, through secure connectivity and cloud platforms, to frontend applications. Thaumatec covers the entire chip-to-cloud scope in-house, including cybersecurity and compliance, which means no gaps between layers and no finger-pointing between vendors.

Cybersecurity in medical devices requires secure-by-design architecture, encrypted communication, access control, vulnerability management, and ongoing monitoring post-launch. Thaumatec holds ISO 27001 certification and integrates cybersecurity practices throughout the entire development process, not as an afterthought.

IoMT, the Internet of Medical Things, refers to connected devices and software that collect and exchange health data. It enables remote patient monitoring, real-time diagnostics, and data-driven clinical decisions. Thaumatec specializes in building secure and compliant IoMT solutions, from the device hardware to the cloud platform, helping you bring smarter, connected products to market.

A partner like Thaumatec can step in at any stage of your project, whether you need help defining your product strategy, building embedded software and hardware, navigating regulatory requirements like ISO 13485 or IEC 62304, integrating AI, or maintaining the system post-launch. Instead of building an in-house team from scratch, you get immediate access to specialists across the full chip-to-cloud stack, with compliance know-how built in from day one.

Look for certified quality management systems like ISO 13485 and ISO 27001 listed on their website, and ask for examples of projects delivered under IEC 62304. Thaumatec displays these certifications openly and has completed 100+ medical device projects following these standards.

The cost depends on device complexity, regulatory requirements, and the scope of work, from embedded software to cloud and AI. There's no one-size-fits-all answer. Thaumatec works with startups and established MedTech companies alike, tailoring team size and scope to your budget and goals. The best starting point is a discovery call to define the scope and get a realistic estimate.

It depends on device complexity, regulatory pathway, and how much is already defined when development starts. A simple device can take 12 to 18 months, while complex systems with full regulatory submission can take several years. Thaumatec helps clients plan realistic timelines from the start and builds compliance into the process to avoid costly delays later

The key is starting with a clear product strategy, choosing a partner with established compliance processes, and not treating regulation as a separate phase. Thaumatec has certified workflows and experienced teams ready to go from day one, which means less time spent figuring things out and more time building the actual product.

Work with a partner who covers the full stack in-house and already has compliance processes in place. Every handoff between vendors and every compliance mistake costs time and money. Thaumatec handles everything from hardware and firmware to cloud and AI under one roof, with ISO-certified quality processes built in from the start.

It requires moving from a proof of concept to a fully documented, tested, and compliant product, which means introducing proper software lifecycle processes, risk management, traceability, and a quality management system. Thaumatec has done this many times and can take your prototype through the entire journey to a market-ready, certified device.

Preparation means having complete technical documentation, clinical evaluation, risk management files, software lifecycle records, and a certified quality management system ready for review. The earlier you start building this documentation, the smoother the submission process. Thaumatec integrates these requirements into the development process from day one, so nothing needs to be retrofitted at the end.

In most cases yes. Both FDA and MDR require clinical evidence demonstrating that your device is safe and performs as intended. The extent of clinical validation depends on your device class and intended use. Thaumatec can help you determine what's required for your specific product and make sure the software is built to support the validation process.

You need a validated product, complete technical documentation, regulatory approval for your target market, a certified quality management system, and a post-market surveillance plan. It's a complex process that requires coordinating development, compliance, and clinical evidence at the same time. Thaumatec supports clients through the entire journey, from first concept to market launch.

Connecting a medical device means choosing the right communication protocol, whether Bluetooth, Wi-Fi, LoRa, or cellular, building secure data transmission, and integrating with a cloud platform for data storage and analysis. It also has to meet cybersecurity requirements for medical devices. Thaumatec handles the full connectivity stack in-house, from firmware to cloud, ensuring everything is secure and compliant.

Every software update to a certified medical device must go through a controlled change management process, including impact assessment, regression testing, and updated documentation. Depending on the change, it may require notifying or resubmitting to the regulatory authority. Thaumatec manages this process as part of their ongoing maintenance services, so updates don't put your certification at risk.

Post-launch compliance requires ongoing post-market surveillance, incident reporting, software updates managed under a controlled process, and regular audits of your quality management system. It's not a one-time effort. Thaumatec offers IT maintenance and managed services to keep your product compliant and up to date long after it hits the market.

Long-term maintenance requires a controlled process for handling updates, bug fixes, security patches, and regulatory changes, all documented and traceable. It's not just keeping the software running, it's keeping it compliant. Thaumatec offers dedicated maintenance and managed services tailored for regulated medical software, so your product stays safe, secure, and market-ready over its entire lifecycle.

Risk management in medical device development requires identifying hazards, evaluating their impact, and implementing mitigations throughout the entire product lifecycle. It's not a one-time exercise but an ongoing process tied to every design and software decision. Thaumatec applies structured risk management as a standard part of their development process, keeping it aligned with both the technical work and regulatory requirements.

The biggest risks are regulatory non-compliance, poor documentation, security vulnerabilities, and underestimating the complexity of certified development processes. These mistakes can delay your market launch by months or even years. Working with an experienced partner like Thaumatec from the start significantly reduces these risks, as compliance and quality are part of their standard process, not an add-on.