Bringing MDR, ISO 13485, and ISO 27001 together into a single, unified management system can provide significant strategic advantages. It creates efficiency, reduces duplication, and helps organizations maintain compliance across quality, regulatory, and information security requirements. At the same time, it is far from straightforward, as each framework brings its own structure, priorities, and challenges.
One of the most common difficulties lies in structural misalignment. ISO 13485 is built on ISO 9001 but uses its own terminology, ISO 27001 follows the Annex SL structure, while MDR is a regulation without a management system framework at all. Aligning these into a coherent system requires careful mapping, documentation harmonization, and cross-referencing.
Risk management is another area where integration can be complex. ISO 13485 prioritizes product safety, ISO 27001 focuses on information security, and MDR extends risk management across the entire device lifecycle, including clinical and post-market phases. For software-based medical devices, this means cybersecurity risks must directly inform product risk assessments, adding another layer of complexity.
Resourcing and expertise often become limiting factors as well. Effective integration demands knowledge across quality assurance, regulatory affairs, and IT security. Smaller organizations in particular may struggle to recruit or train staff who can bridge these domains.
The same challenge arises in documentation management, where extensive requirements under each framework risk leading to duplication and inconsistency unless a centralized, well-structured document control system is established.
Audits and certifications also require thoughtful coordination. Each framework comes with its own cycle and requirements, and although integrated audits are possible, they need careful planning to avoid audit fatigue while ensuring full coverage.
On top of this, cultural barriers within organizations often play a role. Quality, regulatory, and IT teams tend to work in silos, and unifying these systems means fostering a shared culture, language, and set of objectives across very different disciplines.
Finally, organizations must continuously adapt to evolving requirements. MDR continues to develop, and both ISO 13485 and ISO 27001 are subject to periodic revisions. Keeping an integrated system compliant demands ongoing regulatory intelligence and process updates without disrupting daily operations.
At Starodub, we understand both the complexity and the opportunity of integration. With experience across all three domains, we support organizations in building unified management systems that not only meet compliance requirements but also strengthen resilience and efficiency.
