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Secure Software & Product Development

Secure software development from the first line of code to the field: secure coding, a secure development lifecycle (SSDLC), pipeline and supply chain security, and product security by product type — CRA, IEC 62443, UN R155/R156 with ISO/SAE 21434, MDR/IVDR.

Last updated: October 2026 · Valeri Milke, ISO 27001 & ISO 42001 Lead Auditor

Secure software and product development means building security into a product demonstrably across its lifecycle — from design and code to build, release and vulnerability handling in the field. The applicable rules depend on the product type. Hardware and software with digital elements, including industrial components, fall under the Cyber Resilience Act (CRA); for industrial components, the IEC 62443 series is the recognised state of the art, and from 20 January 2027 machinery is additionally subject to the Machinery Regulation. Vehicles need UN R155 and R156 for type approval, usually implemented with ISO/SAE 21434. Medical devices are governed by the Medical Device Regulation (MDR) and the IVDR, with IEC 81001-5-1 as the reference point. Type-approved vehicles and medical devices are excluded from the CRA because sector-specific law applies.

Topics & knowledge pages

Each topic leads to a dedicated knowledge page with deep dives, practical guides and the matching services.

Product security by product type

The product type determines which cybersecurity requirements apply. The four product types at a glance — with scope, key standards and deadlines; where sector-specific legislation applies, the CRA steps back.

CRA — products with digital elements

Cross-sector EU obligations for manufacturers of connected hardware and software — from planning and development to vulnerability handling across the entire lifecycle.

Products
Hardware and software with digital elements — from smart home devices, routers and operating systems to apps
Rules & standards
CRA; harmonised standards (EN 40000 and ETSI EN 304 series) in progress, none in the Official Journal yet; ENISA reporting platform
Key dates
In force 10 Dec 2024 · notified body rules 11 Jun 2026 · reporting obligations 11 Sep 2026 · full application 11 Dec 2027

IEC 62443 — industrial automation & OT

International series of standards for secure development processes, components and systems in industrial automation — voluntary, but the recognised state of the art and the basis for future harmonised CRA standards.

Products
Industrial automation (OT) components and systems, controllers and machinery — for manufacturers, integrators and asset owners
Rules & standards
IEC 62443-4-1 (development process), -4-2 (components), -3-3 (systems), -2-1 (asset owners); CRA; Machinery Regulation
Key dates
Machinery Regulation from 20 Jan 2027 · alignment of EN IEC 62443-4-1/-4-2 with the CRA in progress

Vehicles — UN R155/R156 & ISO/SAE 21434

Cybersecurity is a prerequisite for type approval: vehicle manufacturers need a certified cybersecurity management system (CSMS) and a software update management system (SUMS).

Products
Cars, buses and trucks (M, N), trailers (O) for software updates; new two-/three-wheeler and quad types (L) from 11 Dec 2027
Rules & standards
UN R155 (CSMS), UN R156 (software updates), ISO/SAE 21434 as the engineering standard; excluded from the CRA
Key dates
R155: new types since 6 Jul 2022, all new registrations since 7 Jul 2024 (large series) · R156: existing types since 7 Jul 2026

Medical devices — MDR & IVDR

IT security is part of the general safety and performance requirements of the MDR and IVDR — to be demonstrated before placing on the market and maintained through post-market surveillance and maintenance in the field.

Products
Medical devices and in vitro diagnostic devices, including software as a medical device; excluded from the CRA
Rules & standards
MDR/IVDR, MDCG 2019-16 Rev. 1, IEC 81001-5-1 (recognised reference, not harmonised), AI Act for AI-enabled medical devices, Data Act for connected products
Key dates
MDR since 26 May 2021 · IVDR since 26 May 2022 · AI Act high-risk obligations for AI medical devices from 2 Aug 2028
Consulting · AI Code Security

When rules are no longer enough: code security in the age of AI

Rule-based scanners reliably find syntax flaws. Broken authorization, business logic and wrongly assumed permissions have no signature at all. We bring rules, AI reasoning and exploit validation into an order your team can operate.

  • Layer 1–3 scanning architecture
  • Introduce and calibrate AI SAST
  • Exploit validation
  • Ownership & remediation
  • Evidence for CRA and NIS2
Explore AI Code Security

A consulting service — the knowledge pages above stay freely accessible.

Deep Dives

In-depth knowledge pages on the topics that currently raise the most questions — with verified sources and concrete measures.

Clinical AI Risk Management

How hospitals, practices and laboratories operate AI systems securely: deployer duties under the AI Act and their interplay with the MDR, shared responsibility with the provider, a threat model for medical AI, risk assessment and robust evidence.

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Medical Device Maintenance

How manufacturers and hospitals keep connected medical devices secure in the field: with an inventory and SBOM, clinically grounded triage, patches as controlled changes, coordinated vulnerability disclosure and aligned reporting channels.

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Data Act & Medical Devices

How manufacturers can design the legally required access to device data so that patient safety, health data and trade secrets remain protected – with a threat model, penetration testing and an integrated management system.

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Slopsquatting & coding agents

AI models suggest packages that do not exist — and attackers can register exactly those names. Coding agents with terminal access install whatever they consider right. This deep dive connects typosquatting and slopsquatting in npm and PyPI with a security model for coding agents and their harness: attack chain, five protection layers, obligations under the CRA, NIS2 and DORA, a self-assessment and a CISO whitepaper (in German).

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Automotive Threat Matrix

How the Auto-ISAC matrix describes attacker behaviour against the vehicle – and how it gives the TARA under ISO/SAE 21434, the evidence under UN R155, the OWASP testing catalogues and the Vehicle SOC a common language.

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Secure Coding

How to prevent vulnerabilities systematically: the current landscape of the CWE Top 25 and OWASP Top 10:2025, ASVS 5.0 as a requirements framework, and the practices that make the difference in day-to-day development.

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FAQ

Frequently asked questions on product security by product type

Which rules apply to which product — and where does the Cyber Resilience Act not apply? Short answers to questions that manufacturers and regulatory affairs managers ask most often.

Does the Cyber Resilience Act apply to medical devices?

No. Products covered by the MDR or the IVDR are excluded from the Cyber Resilience Act. Their cybersecurity is governed by the two medical device regulations, with the MDCG 2019-16 Rev. 1 guidance and the IEC 81001-5-1 standard, which has not yet been harmonised, as reference points. Software and devices without a medical intended purpose — general hospital IT, for example — may well fall under the CRA, however.

Does the CRA apply to cars and vehicle components?

Not to type-approved cars, buses, trucks and trailers: they fall under EU type approval, which governs cybersecurity through UN R155 and software updates through UN R156. As a rule, the exclusion also covers systems and components type-approved for such vehicles. Since 2025, a delegated act has additionally excluded two- and three-wheelers and quads; for new types in this category, UN R155 applies from 11 December 2027. Aftermarket products, charging equipment or apps outside type approval, by contrast, may fall under the CRA. Pedal cycles of category L1e also remain within the CRA.

Is IEC 62443 mandatory?

No. IEC 62443 is an international series of standards, not a law. It is, however, regarded as the state of the art for industrial components and is currently being adapted for the CRA — for example through amendments to EN IEC 62443-4-1 and -4-2 and product-specific profiles. The presumption that the legal requirements are met (presumption of conformity) only arises once a harmonised version is cited in the Official Journal of the EU; as of October 2026, this is not the case.

When does the CRA reporting obligation apply, and where do manufacturers report?

Since 11 September 2026, manufacturers have had to report actively exploited vulnerabilities and severe incidents to the competent national CSIRT via ENISA’s Single Reporting Platform. The deadlines: an early warning within 24 hours, a notification within 72 hours and a final report no later than 14 days after a corrective measure becomes available — for incidents, within one month of the notification. The obligation also covers products placed on the market before the cut-off date.

What is the difference between UN R155 and ISO/SAE 21434?

UN R155 is a binding type-approval regulation: without a certified cybersecurity management system (CSMS), a vehicle type will not be approved. ISO/SAE 21434, by contrast, is the engineering standard that manufacturers and suppliers use to implement the required processes, such as threat analysis and risk assessment (TARA). The standard is not legally mandated, but it is the usual way to demonstrate compliance; manufacturers cover gaps such as the R155 threat catalogue separately.

Are there harmonised standards for the CRA yet?

Not yet. The Commission’s standardisation request covers 41 horizontal and product-specific standards. Under a draft amendment that had not been adopted as of October 2026, the first horizontal standards are due by the end of October 2026 and product-specific ones by the end of December 2026. As long as no version is cited in the Official Journal, there is no presumption of conformity: manufacturers must substantiate compliance with the requirements themselves, and important products of class I then require a notified body.

Make security part of your development

In an initial consultation, we assess your SSDLC maturity — and show you which measures in your pipeline, code and product approval offer the greatest leverage.