INDUSTRY FACT FILE · MEDICAL DEVICES & MEDTECH

Cybersecurity FAQs for Medical Device Manufacturers

Forty frequently asked questions and answers in five categories, written for leadership, R&D, regulatory, quality, product security and platform teams.

In this document 1.  Category 1: Product security strategy 2.  Category 2: Regulation and submissions 3.  Category 3: Firmware, hardware and connectivity 4.  Category 4: Apps, cloud and data 5.  Category 5: SBOM, vulnerabilities and incidents

Audience: CEOs, Boards and R&D leaders

Q1. Why does medical device cybersecurity matter?

Vulnerable devices can be manipulated, disrupted or used to expose patient data, affecting safety and market access.

Q2. What are the biggest risks?

Firmware flaws, hard-coded credentials, insecure updates, debug ports, wireless and app weaknesses, vulnerable components and cloud platform flaws.

Q3. Which examples illustrate the risk?

A 2017 FDA-announced firmware update for about 465,000 pacemakers and a January 2025 US warning about a patient monitor with a hidden data function.

Q4. Who owns product security?

Engineering and R&D, with product security, quality, regulatory and leadership accountable together.

Q5. What should leadership review?

Threat models, test results, SBOM status, vulnerability backlog, disclosure cases and regulatory evidence readiness.

Q6. When should security start?

At design. Retrofitting security late increases cost and can delay approvals.

Q7. How should we prioritise investment?

Threat modelling, secure updates, unique device identities and an SBOM first; then deeper testing and post-market programmes.

Q8. How can Codec Networks help?

Codec Networks provides threat modelling, firmware and hardware testing, device and API security, secure update reviews, SBOM support and regulatory evidence.

Audience: Regulatory affairs and quality teams

Q9. How are medical devices regulated in India?

Under the Medical Devices Rules, 2017, with risk-based Classes A to D; licensing was phased in for all classes by October 2023.

Q10. Does CDSCO address software cybersecurity?

Yes. CDSCO finalised guidance on medical device software in 2026 after an October 2025 draft, addressing cybersecurity and component transparency (as reported).

Q11. What does FDA section 524B require?

Premarket submissions for cyber devices must include a cybersecurity plan, SBOM, vulnerability management and design controls.

Q12. What does the EU MDR require?

IT security and protection against unauthorised access within its general safety and performance requirements, supported by MDCG guidance.

Q13. Which standards help?

IEC 81001-5-1 for secure lifecycle, IEC 62304 for software lifecycle and ISO 14971 for risk management.

Q14. What is a cyber device?

Under FDA's definition, a device that includes software, can connect to the internet and could be vulnerable to cybersecurity threats.

Q15. Does DPDP apply to device data?

Yes, where devices and platforms process personal data; most DPDP obligations take effect in May 2027.

Q16. Can Codec Networks prepare evidence?

Yes. Codec Networks produces threat models, test reports and SBOM analyses structured for submissions.

Audience: Embedded, hardware and firmware engineers

Q17. What does firmware testing involve?

Extracting and analysing firmware for vulnerabilities, secrets, insecure configurations and unexpected behaviour.

Q18. How should debug interfaces be handled?

Disable or lock JTAG, SWD and UART in production, and verify this during testing.

Q19. Why use unique device keys?

Shared keys let one compromised unit expose or impersonate the whole fleet.

Q20. How should BLE be secured?

Use authenticated pairing, encryption and protections against replay and unauthorised commands.

Q21. What is secure boot?

A mechanism that verifies firmware signatures at start-up so only trusted code runs.

Q22. How should updates be delivered?

Signed firmware, verified on the device, from hardened servers, with staged rollout and rollback.

Q23. How do we test robustness?

Fuzz network and wireless interfaces to ensure malformed input cannot crash or compromise the device.

Q24. What about legacy devices in the field?

Provide compensating guidance, monitor for vulnerabilities and plan updates or replacement.

Audience: Platform, app and privacy teams

Q25. How should companion apps be secured?

Protect stored data and secrets, use secure APIs and test on real devices.

Q26. How should device-to-cloud identity work?

Use per-device certificates or keys, never a shared API key.

Q27. What platform authorisation is needed?

Per-device and per-patient checks on every API so users see only their data.

Q28. How should patient data be protected?

Encrypt in transit and at rest, minimise collection and control access.

Q29. Do platforms need monitoring?

Yes. Monitor identity, API usage and anomalies, and be ready to report incidents to CERT-In within six hours.

Q30. How do we secure SaMD and AI features?

Test applications and APIs, protect models and validate behaviour against manipulated inputs.

Q31. How should hospitals integrate our devices?

Provide security documentation, network requirements and hardening guidance.

Q32. What about data from home devices?

Treat consumer networks as untrusted and protect data end to end.

Audience: Product security, quality and support teams

Q33. What is an SBOM?

A list of software components in a product, used to track and manage vulnerabilities.

Q34. How should we manage component vulnerabilities?

Monitor advisories against the SBOM, assess impact and patch or mitigate within defined timelines.

Q35. What is coordinated vulnerability disclosure?

A process for receiving reports from researchers, fixing issues and informing customers responsibly.

Q36. Do we need a PSIRT?

A product security incident response function is expected by regulators and customers.

Q37. How should we handle a field vulnerability?

Assess safety impact, coordinate with regulators where required, issue advisories and deliver updates.

Q38. How should suppliers be managed?

Set security requirements, request SBOMs and assess component suppliers and contract manufacturers.

Q39. Should we run product incident exercises?

Yes—with engineering, quality, regulatory and communications teams.

Q40. How can we start with Codec Networks?

Begin with a scoping call on your products, markets and timelines; Codec Networks will propose a threat modelling and testing plan.

Contact Codec Networks Pvt. Ltd. New Delhi: 507, 5th Floor, New Delhi House, Barakhamba Road, Connaught Place, New Delhi – 110001 Gurugram: 707, 7th Floor, Silverton Tower, Golf Course Extension Road, Sector 50, Gurugram – 122018, Haryana Landline: 011 430 496 96 | 011 437 522 99   Mobile: +91 99716 76124 | +91 88007 88220 | +91 88003 31124 Email: mktg@codecnetworks.com   Web: www.codecnetworks.com

Note: These FAQs provide general guidance as of October 2026 and do not constitute regulatory advice. Confirm requirements against the official instruments for each product and market.