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INDUSTRY FACT FILE · MEDICAL DEVICES & MEDTECH
Applicable Cybersecurity Services and Codec Networks Bundles for Medtech
How Codec Networks services and bundled service models help medtech companies secure their products and meet CDSCO, FDA 524B, EU MDR and standards expectations.
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In this document 1. Our approach 2. Mapping threats to services 3. Codec Networks service catalogue for the sector 4. Codec Networks bundles for the sector 5. Sector programmes built from the bundles 6. Packages: Foundation, Assurance and Continuous Resilience 7. Regulatory requirement-to-bundle mapping 8. Threat-to-bundle coverage matrix 9. Delivery methodology and deliverables 10. Why Codec Networks 11. Annex: indicative commercial ranges |
1. Our approach
Medtech needs product security that spans hardware, firmware, connectivity and cloud. Codec Networks works on four principles:
- Design it in: threat models tied to safety risk files.
- Test every layer: firmware, hardware, wireless, apps and cloud.
- Protect the fleet: signed updates, unique identities and SBOMs.
- Evidence for approval: documentation regulators and hospitals expect.
2. Mapping threats to services
The table maps the 18 threats identified in Document 4 of this set to the Codec Networks services that help mitigate them.
|
Threat / challenge |
Applicable Codec Networks services |
Intended outcome |
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Firmware vulnerabilities |
Firmware analysis and testing |
Fewer exploitable flaws |
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Hard-coded credentials and backdoors |
Secrets and behaviour analysis |
No hidden access |
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Insecure wireless |
BLE and Wi-Fi testing |
Authenticated connections |
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Insecure updates |
Secure update and boot review |
Trusted firmware only |
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Exposed debug interfaces |
Hardware security testing |
Locked production devices |
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Vulnerable components |
SBOM and component analysis |
Known, managed components |
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Cloud API flaws |
API and cloud testing |
Protected patient data |
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Mobile app flaws |
Mobile app testing |
Secure companion apps |
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Patient data exposure |
Encryption and DPDPA review |
Protected data |
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Legacy operating systems |
Platform hardening review |
Reduced exposure |
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Service tool misuse |
Service tool and access review |
Controlled maintenance |
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Supply-chain compromise |
Supplier and provisioning assessments |
Trusted manufacturing |
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Shared device keys |
Identity and provisioning review |
Unique device identities |
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AI manipulation |
AI and model security testing |
Robust AI features |
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Ransomware via networks |
Network resilience testing |
Resilient devices |
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Denial of service |
Robustness and fuzz testing |
Stable operation |
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Weak vulnerability handling |
PSIRT and disclosure programme |
Faster fixes |
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Insufficient evidence |
Threat modelling and submission evidence |
Faster approvals |
3. Codec Networks service catalogue for the sector
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Service line |
Sector-relevant services |
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Security Vulnerability Assessment & Penetration Testing |
Device, embedded, firmware, hardware and network testing; fuzzing and robustness testing |
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Application, API & DevSecOps security |
Companion apps, device-to-cloud APIs, secure updates, SBOM and secure development |
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Cloud security |
Remote monitoring platform, device identity and IoT cloud reviews |
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Information security audit & compliance |
FDA 524B, EU MDR and CDSCO evidence; IEC 81001-5-1 lifecycle readiness |
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Product threat modelling |
Threat models and security risk assessments aligned to ISO 14971 |
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Data privacy & protection |
Patient data handling in devices and platforms, DPDPA readiness |
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24/7 Managed SOC & threat monitoring |
Platform and fleet monitoring |
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Cyber forensics |
Device and platform incident investigation |
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Third-party risk management |
Component supplier and contract manufacturer assessments |
4. Codec Networks bundles for the sector
Eleven of the twelve bundles in the Codec Networks Bundled Service Models apply directly to medical device and medtech companies; the Global Cyber Back-Office SPV Program (Bundle 12) is offered separately for international clients.
Figure 6: Codec Networks bundles applied to the sector.
|
Bundle |
Name |
Sector-relevant scope |
Best suited for |
Key deliverables |
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B1 |
Cyber Assessment & VAPT Assurance Program |
Device, firmware and hardware testing |
All device makers |
Test reports and closure tracker |
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B2 |
Application, API & DevSecOps Security Program |
Companion apps, APIs, secure updates and SBOM |
Connected device makers |
Application, API and update risk report |
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B3 |
Cloud, Infrastructure & Zero Trust Security Program |
Remote monitoring cloud and identity reviews |
Platform providers |
Cloud review report |
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B4 |
Regulatory Cybersecurity Audit & Compliance Assurance Program |
FDA 524B, EU MDR and CDSCO evidence |
Exporting and regulated manufacturers |
Submission evidence pack |
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B5 |
GRC, ISO, SOC 2 & Cyber Maturity Program |
IEC 81001-5-1 lifecycle and ISO 27001 |
Manufacturers formalising product security |
Gap assessment, procedures |
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B6 |
Data Privacy, DPDPA & Data Protection Program |
Patient data protection for devices and platforms |
Platforms and app-connected devices |
Privacy gap assessment |
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B7 |
Managed SOC, MDR & Continuous Threat Monitoring Program |
Platform and fleet monitoring |
Platform providers and OEMs |
Monitoring reports |
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B8 |
Digital Forensics, Incident Response & Malware RCA Program |
Device and platform incident response |
Any company facing an incident |
Forensic report and RCA |
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B9 |
Third-Party Risk Management & Supply Chain Cyber Risk Program |
Component supplier and EMS assessments |
OEMs with complex supply chains |
Supplier risk assessments |
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B10 |
Cyber Simulation, Awareness, Tabletop & Crisis Readiness Program |
Product incident and disclosure exercises |
Engineering, quality and regulatory teams |
Exercise reports |
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B11 |
Emerging Technology, AI, Web3 & Future Security Program |
AI-enabled device and SaMD security |
AI medical software developers |
AI risk assessment |
5. Sector programmes built from the bundles
Codec Networks packages the catalogue bundles into six medtech programmes.
|
Programme |
Built from bundles |
Challenges addressed |
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Secure by Design Programme |
B2, B5 |
Threat modelling and secure lifecycle |
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Device Security Testing |
B1, B2 |
Firmware, hardware, wireless and apps |
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Secure Update & Identity |
B2, B3 |
Signing, boot, update servers and keys |
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Regulatory Evidence Programme |
B4, B5 |
FDA 524B, EU MDR and CDSCO |
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SBOM & PSIRT Programme |
B2, B9, B10 |
Components, disclosure and post-market |
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Platform Security |
B3, B6, B7 |
Remote monitoring cloud and patient data |
6. Packages: Foundation, Assurance and Continuous Resilience
|
Package element |
Foundation |
Assurance |
Continuous Resilience |
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Typical organisation |
Start-ups and first-product teams |
Growing manufacturers |
Established OEMs and platforms |
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Testing |
B1: firmware and app test |
B1 + B2: device, API and cloud testing |
B1 + B2 + B10: continuous product testing |
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Audit and GRC |
B4: submission checklist |
B5: IEC 81001-5-1 gap assessment |
B4 + B5 + B9: evidence, lifecycle and supplier assurance |
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Cloud and privacy |
B2: SBOM generation |
B3 + B6: platform and data protection |
B3 + B6 + B11: platform, data and AI assurance |
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Monitoring and response |
IR retainer (B8) |
B7: platform monitoring + B8 |
B7: fleet and platform SOC + B8 |
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Reporting |
Threat model and test report |
Regulatory evidence pack |
Post-market and Board reporting |
7. Regulatory requirement-to-bundle mapping
|
Requirement (source) |
How Codec Networks helps |
Bundle |
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Device licensing and quality documentation (Medical Devices Rules, 2017) |
Security evidence for quality files |
B4 |
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Cybersecurity of medical device software (CDSCO guidance) |
Software security assessment and documentation |
B2, B4 |
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Cybersecurity plan and vulnerability management (FDA 524B) |
Threat model, test evidence and PSIRT design |
B4, B5 |
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Software bill of materials (FDA 524B) |
SBOM generation and analysis |
B2 |
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IT security in general safety requirements (EU MDR) |
Cybersecurity documentation and testing |
B4, B1 |
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Secure product lifecycle (IEC 81001-5-1) |
Lifecycle gap assessment |
B5 |
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Patient data safeguards (DPDP) |
DPDPA programme for device data |
B6 |
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Cyber incidents to CERT-In within six hours (platforms) |
Platform monitoring and IR |
B7, B8 |
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Auditor eligibility and independence Where a regulator, standard or contract requires CERT-In empanelled or independent auditors, Codec Networks—CERT-In empanelled for information security auditing services—confirms eligibility and independence in each proposal. |
8. Threat-to-bundle coverage matrix
|
Threat / challenge |
Primary bundle |
Supporting bundles |
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Firmware vulnerabilities |
B1 |
B2 |
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Hard-coded credentials |
B1 |
B9 |
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Insecure wireless |
B1 |
B2 |
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Insecure updates |
B2 |
B3 |
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Debug interfaces |
B1 |
B5 |
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Vulnerable components |
B2 |
B9 |
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Cloud API flaws |
B3 |
B2 |
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Mobile app flaws |
B2 |
B1 |
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Patient data exposure |
B6 |
B3 |
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Legacy OS |
B1 |
B5 |
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Service tool misuse |
B1 |
B3 |
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Supply chain |
B9 |
B1 |
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Shared keys |
B2 |
B1 |
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AI manipulation |
B11 |
B2 |
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Ransomware via networks |
B1 |
B10 |
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Denial of service |
B1 |
B2 |
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Weak vulnerability handling |
B5 |
B10 |
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Insufficient evidence |
B4 |
B5 |
“Primary” and “supporting” indicate suggested combinations, not guaranteed mitigation or complete coverage.
9. Delivery methodology and deliverables
Figure 7: The Codec Networks delivery methodology.
Typical deliverables include a product threat model, firmware, hardware, wireless, app and cloud test reports with retests, an SBOM and component risk analysis, a secure update review, an IEC 81001-5-1 gap assessment and a regulatory evidence pack for FDA, EU and CDSCO submissions.
10. Why Codec Networks
- CERT-In empanelled for information security auditing services, and empanelled with NICSI for application audit and compliance services (start-up category).
- Certified to ISO 9001:2015, ISO/IEC 27001:2022 and ISO/IEC 20000-1:2018.
- Full stack: VAPT, regulatory audit, managed SOC, forensics, privacy and Board advisory from one partner, so findings, monitoring and closure stay connected.
- Medtech depth: firmware, hardware, wireless, apps, update channels and cloud platforms tested together, with evidence structured for regulators.
- Recognised frameworks and tools: OWASP ASVS/MASVS and API Top 10, MITRE ATT&CK, NIST CSF, ISO 27001 and PCI DSS; tools such as Burp Suite, Nessus, Metasploit, Prowler and leading SIEM/EDR platforms.
- Certified people: CEH, OSCP, CPENT, CISA, ISO 27001 LA/LI, CHFI, CTIA and ECIH professionals.
Annex: Indicative commercial ranges
For internal sales reference only—remove this annex before sharing externally. Ranges are taken from the Codec Networks Bundled Service Models and are subject to scoping, asset counts, frequency and service levels.
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Bundle |
Package examples and indicative ranges |
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B1 VAPT Assurance |
Essential ₹1.5–5 lakh; Professional ₹5–15 lakh; Enterprise ₹15–40 lakh; Annual retainer ₹25 lakh–₹1.5 crore |
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B2 AppSec & DevSecOps |
API Quick Check ₹2–6 lakh; AppSec Professional ₹8–20 lakh; DevSecOps Maturity ₹12–35 lakh; Secure SDLC retainer ₹3–15 lakh/month |
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B3 Cloud & Zero Trust |
Cloud Essential ₹3–8 lakh; Professional ₹8–25 lakh; Enterprise ₹25–75 lakh; Continuous assurance ₹2–10 lakh/month |
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B4 Regulatory Audit |
Gap review ₹5–15 lakh; Full regulatory audit ₹15–50 lakh; Multi-framework audit ₹30 lakh–₹1.25 crore; Annual retainer ₹3–20 lakh/month |
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B5 GRC, ISO, SOC 2 |
ISO readiness ₹5–15 lakh; ISO implementation ₹15–45 lakh; SOC 2 readiness ₹15–60 lakh; GRC retainer ₹2–12 lakh/month |
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B6 Privacy & DPDPA |
Quick assessment ₹3–10 lakh; Implementation ₹10–40 lakh; DPO-as-a-Service ₹2–8 lakh/month; Privacy retainer ₹3–15 lakh/month |
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B7 Managed SOC |
Starter ₹2–5 lakh/month; Professional ₹5–15 lakh/month; Enterprise ₹15–50 lakh/month; co-managed per FTE/shift |
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B8 Forensics & IR |
Triage ₹3–15 lakh; Full investigation ₹15–75 lakh; Ransomware response ₹25 lakh–₹1.5 crore; IR retainer ₹5–50 lakh/year |
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B9 TPRM |
₹25,000–₹2 lakh per vendor; batch pricing for 50–500 vendors; retainer ₹3–25 lakh/month |
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B10 Simulation & Tabletop |
Awareness ₹1–5 lakh; Phishing simulation ₹2–10 lakh; Tabletop ₹5–20 lakh; Cyber war-game ₹15–75 lakh; Annual retainer ₹10 lakh–₹1 crore/year |
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B11 Emerging Tech |
AI/LLM risk review ₹5–25 lakh; Smart contract audit ₹5–50 lakh; Emerging tech retainer ₹5–25 lakh/month |
Talk to Codec Networks
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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: Service scope, deliverables, monitoring coverage and service levels are confirmed during engagement scoping. Services support risk reduction and assurance but do not guarantee prevention of all cyber incidents or regulatory compliance. Regulatory references are summaries; confirm against the official instruments applicable to each entity.