Medical Device Software, SaMD & Cybersecurity

Under MDR Rule 11 and IVDR, standalone software frequently up-classifies to Class IIa, IIb or Class C. We build the complete technical file connecting medical function, software architecture, risk controls and clinical evaluation.

Discuss Your EU Software Regulatory Strategy

Software Lifecycle & Cybersecurity Deliverables

Software qualification as medical device / IVD and Rule 11 classification strategy

Software lifecycle planning strictly aligned with IEC 62304 (Class A, B, C)

Software architecture, SOUP / OTS third-party software and configuration management

Software requirements, verification, code review and automated validation testing

Usability engineering and user-interface risk mitigation (IEC 62366-1)

Cybersecurity risk management and secure development lifecycle (MDCG 2019-16)

Interoperability, cloud/mobile environments and data-interface validation

Clinical evaluation / performance evaluation of algorithmic and AI/ML functions

PMS strategy for software versioning, vulnerability monitoring and OTA field updates

Reviewer Lens

Link Medical Function Directly to Verification & Clinical Claims

A software technical file can be technically complete with code repositories and unit tests, but still face severe Notified Body pushback if the intended medical function, classification rules, risk controls and clinical/performance claims are not consistently harmonized.

Applicable European Guidance

• MDCG 2019-11: Qualification & Classification of Software

• MDCG 2019-16: Cybersecurity Requirements

• MDCG 2020-1: Clinical Evaluation of SaMD

• IEC 62304 & IEC 82304-1: Health Software

SaMD Pre-Assessment

Evaluate your software architecture and cybersecurity documentation before Notified Body review.

Review Software File

Bring Compliant Medical Device Software to the European Market

Our software regulatory engineers bridge the gap between agile coding sprints and strict Notified Body compliance.

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