Connected medical devices are collecting more data than ever — and that makes them a target. But while the risks are growing, many startups still underinvest in security.
Yet, many medical device manufacturers and healthcare organizations still put medtech cybersecurity on the back burner. Around 32% of medtech executives cite the lack of data privacy and security as one of the main connected care adoption hurdles. If this trend continues, the global connected care market may experience a slowdown in growth, which is projected to reach $152 billion by 2030 from $75.99 billion in 2025.
In this article, we’ll look into must-know regulatory guidelines for medical device cybersecurity that manufacturers, healthcare providers, and developers must follow to keep hackers at bay.
Global frameworks for medical device cybersecurity
According to the FDA, more than half of connected medical devices in hospitals had known critical vulnerabilities, and 40% of devices at the end-of-life stage had few or no security patches. Although this is a compound problem, a tangle of regulations is one of the reasons why manufacturers can’t properly implement or delay security measures. To address this challenge, regulatory bodies have been developing more harmonized frameworks for the medical device industry.
FDA’s final guidance on premarket cybersecurity for the US market
Until October 1, 2023, the FDA’s (Food and Drug Administration) guidance on medtech cybersecurity was non-binding in the U.S. However, the FDA’s final guidance titled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions flipped the script. Starting October 1, 2023, the FDA has the authority to 1) mandate cybersecurity details in medical device submissions for “cyber devices” and (2) make sure these devices achieve basic cybersecurity standards.
The new direction replaces the agency’s 2014 final guidance titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” formalizing and elaborating on the following cybersecurity concepts:
- Security-by-design — The policy explicitly requires manufacturers to integrate cybersecurity as early as the initial design stage and all the way to post-deployment.
- SBOM (Software Bill of Materials) — Device manufacturers must submit a detailed list of all software components that power their medical devices.
- SPDF (Secure Product Development Framework) — The guidance confirms an end-to-end cybersecurity approach throughout the entire product lifecycle, including security risk management, security architecture, and cybersecurity testing. The IEC 81001-5-1 standard is referenced as a possible framework to implement the SPDF.
- ANSI/AAMI SW96:2023 — Although this standard isn’t a part of the FDA’s October 2023 guidance, it was officially recognized by the FDA in November 2023 as a consensus standard for demonstrating compliance with cybersecurity expectations. It’s designed to parallel ISO 14971.
- Risk categorization — This guidance classifies medical devices into Tier 1 (higher risk) and Tier 2 (lower risk) devices based on their risk profile.
EU MDR and IVDR cybersecurity provisions
The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) regulate medical devices and in vitro medical devices within the EU market. Unlike the FDA, these regulations don’t offer a deep dive into medical device cybersecurity. The policies take a more subtle approach, viewing it as an integral part of overall medical device safety and performance.
According to the directives, medical device manufacturers are obligated to:
- Treat cybersecurity as a safety issue and integrate cybersecurity into their quality management and risk management systems according to the ISO 14971 standard.
- Implement cybersecurity measures throughout the entire product lifecycle (post-market monitoring included).
- Document cybersecurity measures as part of technical documentation
- Meet global standards and best practices, such as IEC 81001-5-1, IEC 62304, and ISO/IEC 27001, and more.
Bottom line, EU regulations have a compound vision of cybersecurity and safety — and demand that manufacturers approach it not as a standalone issue, but as a core pillar of a device’s risk profile.
👉 If a manufacturer is venturing into both the US and EU markets, they can use the FDA’s SPDF as a baseline for international compliance.
IEC 81001-5-1:2021, ISO/IEC 27001, and IEC 62304 for harmonized compliance
IEC 62304, IEC 81001-5-1, and ISO/IEC 27001 are three complementary frameworks that help medical device companies develop a unified, internationally accepted compliance strategy. Both the FDA and the MDR recognize these standards, so applying them can save manufacturers from expensive security retrofits down the road.
- The IEC 62304 standard outlines a framework for medical device software lifecycle processes. This framework is essentially not about cybersecurity; it focuses on the overall functional safety of the medtech solution. However, the IEC 62304 standard usually backs up a larger compliance strategy and can serve as a baseline for cybersecurity since safety and security go hand in hand.
- The IEC 81001-5-1:2021 standard fills the cybersecurity gaps in 62304. It gives development teams an understanding of the security tasks and design controls they have to implement across the software lifecycle. The standard already aligns with the risk management standard of ISO 14971, meaning that developers don’t have to set up two separate risk processes to comply with the FDA and EU MDR/IVDR.
- As a gold security standard, ISO/IEC 27001 defines the ISMS, policies, roles, response, and infrastructure protection that companies must apply at an organizational level. It zooms out from the product to the overall security posture of an organization and the infrastructure behind medical software.
The 2022 revision of ISO/IEC 27001 has advanced the standard, taking into account the increased complexity of security threats since the last iteration. Although the changes were mostly cosmetic, the new version introduced a list of updated 27001 controls that derive from ISO 27002:2022.
ISO 14971 for risk management
ISO 14971 is a global risk management standard for medical device companies. Unlike IEC 62304, ISO/IEC 27001, and IEC 81001-5-1, it doesn’t dwell on the prescriptive cybersecurity controls. The standard describes best practices for identifying, evaluating, and monitoring risks, including those related to cybersecurity.
Following this standard gives companies a risk management structure necessary to secure FDA and/or MDR clearance. Also, both IEC 81001-5-1 and ANSI/AAMI SW96 were designed with ISO 14971 in mind so that development teams can assess safety and security risks side by side.
NIST framework for refining core infrastructure cybersecurity
NIST, short for National Institute of Standards and Technology, adds a voluntary practical overlay to theoretical ISO/IEC standards. While ISO/IEC guidelines tell medtech companies what they should do, NIST gives a reference point for how it should be done. This framework is not non-binding, yet regulatory bodies such as the FDA and the MDR strongly encourage its implementation.
Manufacturers can also turn to the NIST framework to benchmark their cybersecurity practices, bridge gaps in incident response plans, and systematize their cybersecurity acts across the software lifecycle.
The U.S. Department of Health and Human Services (HHS) also used NIST as a foundation for its Healthcare Cybersecurity Performance Goals (CPGs), which are a healthcare-specific set of essential and advanced cybersecurity practices.
Core cybersecurity principles for medical devices
Besides standards and checklists like ISO/IEC 27001 and IEC 81001-5-1:2021, medical device companies should also develop their products with an eye on foundational security principles. The latter sets a thinking pattern for medical device cybersecurity that helps companies make decisions when standards leave room for interpretation.
Secure by design
Digital products developed with this principle in mind mark the security of customers as a high-priority business requirement. Instead of adding security later, developers who follow this principle integrate it into the system from the very beginning. Although this is one of the key FDA’s expectations, this principle is not unique to this regulation only — it’s a broader industry standard.
In development, the security by design principle manifests as:
- Threat modeling to shape the software design;
- Secure coding practices such as input validation, data encryption, exception handling, and others;
- Robust authentication and access controls introduced early;
- Continuous security testing, and more.
Defense in depth
According to this principle, medical device security shouldn’t rely solely on a single point of defense. Instead, multiple lines of defense stand in the way of an attack, keeping the product resilient to cybersecurity risks and maximizing patient safety. Common layers of defense include physical security, network security, data protection, endpoint security, and other safety nets.
Least privilege and zero trust
The principle of least privilege (POLP) recommends that users, processes, and devices have only the minimum access they need to achieve the task. POLP is also used as a part of zero-trust network access (ZTNA). The latter assumes no implicit trust, requiring every access request to be verified, no matter the origin.
Technically, POLP is implemented through role-based access control and device-level restrictions. ZTNA, on the other hand, is enforced through micro-segmentation, continuous authentication, dynamic access policies, and encrypted communication. Instead of trusting users based on their network location, ZTNA analyzes each request based on a number of factors, including location, user identity, and more.
Continuous risk management and threat modeling
The cyber threat landscape is never static, especially with the growing interoperability and connectivity of medical devices. That’s why healthcare companies require a living risk management strategy that accounts for evolving threats throughout the entire product lifecycle. Combined with ISO 14971, this approach allows teams to extend standard safety-centered risk assessment to also include cybersecurity threats.
Premarket cybersecurity requirements for medical devices
In the US, before a medical device hits the market, manufacturers have to meet all requirements in terms of premarket cybersecurity requirements. By complying with them, medical device companies demonstrate the effectiveness of their products to regulatory bodies and their dedication to addressing cybersecurity risks from day one.
In particular, the FDA’s final guidance on premarket submissions expects manufacturers to have the following documentation:
- Risk categorization justification (to explain why the device falls into Tier 1 or Tier 2)
- Detailed cybersecurity documentation, including SBOMs, threat models, security use cases, testing reports, description of security controls and mitigations, and evidence of secure product development processes.
- For Tier 1 devices, the FDA usually expects more detailed testing evidence, including static/dynamic analysis, vulnerability scanning, and penetration testing.
- Both Tier 1 and Tier 2 devices are required to demonstrate traceability between identified threats, mitigations, and design controls — which is often done through methodologies like TARA (Threat Analysis and Risk Assessment).
In the EU, the MDR and IVDR don’t have a standalone cybersecurity submission requirement. However, cybersecurity still must be addressed as part of the devices’ technical documentation and risk management files.
Postmarket cybersecurity considerations for medical devices
After the medical device enters the market, manufacturers are expected to maintain the same high standards as before to prevent cybersecurity incidents and keep up with the evolving threats.
The US and EU seem to have a similar understanding of what the effective post-market security looks like. In both regions, postmarket cybersecurity is a continuous, lifecycle-wide responsibility. According to the FDA’s guidance on Postmarket Management of Cybersecurity in Medical Devices, manufacturers must:
- Implement coordinated vulnerability disclosure (CVD) processes, which are formal procedures to handle and disclose cybersecurity vulnerabilities.
- Deliver timely fixes through structured patch and update mechanisms.
- Ensure continuous monitoring and anomaly detection (plus, monitoring through integration with SIEM systems for high-risk devices)
- Have a defined strategy for device lifecycle security planning.
In the EU, similar expectations fall under the MDR and IVDR and are considered components of overall device safety and performance. In other words, manufacturers have to:
- Set up processes to handle vulnerabilities, relying on an international standard such as ISO/IEC 29147 and 30111.
- Maintain postmarket surveillance (PMS) systems that track cybersecurity incidents and feed into corrective and preventive actions (CAPA).
- Update software security to sustain and ensure patient safety.
- Reflect lifecycle security in tech documentation and risk management plans.
Software supply chain security for third-party medtech software
Usually, modern medtech isn’t developed from scratch — it relies on third-party software for pre-made functionality. External components introduce additional cybersecurity risks, triggering further regulatory requirements for manufacturers.
In the US, medtech companies must include a Software Bill of Materials for all device software, even legacy products, to ensure transparency into external software components used. Also, medical device manufacturers are strongly encouraged to leverage automated tools to look for known software weaknesses and incorporate those checks into their QMS processes.
As for the EU, companies are obligated to watch for supply chain security risks throughout the entire device lifecycle, using international standards such as ISO/IEC 27001 and IEC 81001-5-1 as reference points.
Cybersecurity best practices for startups
As a healthcare development company with over 14 years of experience, here are startup-friendly security practices an emerging medtech company can implement to lay the foundation for solid cybersecurity:
- Start early — Adding cybersecurity to an almost-ready product is an expensive side project. Embed security right from the MVP stage, including during requirements gathering, tech stack planning, and vendor selection.
- Collaborate with security experts during architecture planning — As a tech partner, we involve dedicated security consultants early on. This helps project stakeholders gain a detailed understanding of potential risks, select secure technologies, and design a system that’s resilient by default.
- Document and trace everything — Even during early decision-making, jot down your security decisions, third-party libraries, and risk assessments. Otherwise, you’ll have to dig through code commits and emails to reproduce your security rationale.
- Keep your SBOM in order from the very beginning — We’ve also worked with clients who underinvested in dependency tracking and ended up untangling vulnerable libraries for weeks. Maintaining an SBOM from the first release with tools like CycloneDX or SPDX will save you from this scenario.
- Automate Common Vulnerabilities and Exposures (CVEs) monitoring — Make vulnerability scanners and automated CVE monitoring a part of your pipeline. In our projects, we often turn to tools like Snyk, Dependabot, or GitHub security alerts to identify known vulnerabilities without spending too much manual effort.
- Vet vendors like they’re part of your team — If you’re using a third-party software for components like image processing or remote monitoring, make sure to check their security track record just as you would with internal code.
- Budget for lifecycle security — We recommend medtech startups include security as a recurring line item in their budget to cover current security needs and those to come (post-market surveillance and incident response planning).
How Orangesoft helps medtech startups stay secure
As a healthcare tech development partner, our company is keenly aware of how important early cybersecurity management is for medtech companies. Our team builds cybersecurity into every stage of the product development lifecycle, supporting medical device companies on their journey to regulatory clearance.
- Our team establishes and maintains a secure SDLC aligned with OWASP and NIST guidelines.
- We operate under both our internal software development processes, aligned with regulatory standards (e.g., FDA 21 CFR Part 11, ISO 13485, IEC 62304), or adapt to client-specific SOPs, ensuring full compliance with their internal QMS (that was the case when we worked on a virtual hospital platform for one of our clients).
- Our development experts document all third-party components and generate an SBOM using SPDX or CycloneDX formats.
- We engage security consultants to contribute to early-stage architecture planning.
- Our team helps companies prepare documentation for pre-submission, like we did for a post-stroke patient monitoring app.
- After launch, we handle incident response, security patching, and postmarket surveillance.
Whether you’re working on a mobile diagnostic app or a complex connected device, we’ll help you integrate cybersecurity from the start — so you can innovate confidently without last-minute compliance headaches.