EU MDR consulting
Technical documentation that presents a coherent case for the device.
Zaliance supports cardiovascular manufacturers preparing or maintaining technical documentation under the European Union Medical Device Regulation.
The work connects the device description, intended purpose, claims, risk management, verification and validation, clinical evaluation, and post-market activities.
Documentation assessment & remediation planning
Review existing documentation for missing evidence, inconsistencies, and unresolved questions. Establish priorities and responsibilities for remediation.
Deliverables may include: gap assessments, documentation inventories, and remediation plans.
Technical documentation development
Develop and revise technical documentation, including device descriptions, General Safety and Performance Requirements mappings, labeling, and summaries of supporting evidence.
Deliverables may include: technical documentation sections, evidence cross-references, and consistency reviews.
Clinical evaluation
Develop or update clinical evaluation documentation around the device’s intended purpose, claims, available clinical evidence, and relevant safety and performance questions.
Deliverables may include: clinical evaluation plans, literature reviews, clinical evaluation reports, and evidence-gap assessments.
Post-market surveillance & clinical follow-up
Develop post-market surveillance and post-market clinical follow-up plans that address the device and the questions requiring continued evaluation.
Support the connection between post-market findings, clinical evaluation, risk management, and product changes.
Deliverables may include: PMS and PMCF plans, report support, and documentation updates.
Notified body questions & findings
Assess review comments, coordinate the supporting work, and prepare responses that address both the question and affected documentation.
Deliverables may include: response matrices, revised documentation, and corrective-action support.
EU MDR insights
Analysis of technical documentation, clinical evaluation, and post-market evidence.
EU MDR
What determines the EU risk class of cardiovascular software?
EU software classification connects intended clinical use to the consequences of erroneous information. That reasoning also informs evidence, budget and conformity assessment.
EU MDR
What do the EU’s new notified-body timelines mean for your launch plan?
The EU's new notified-body rules define assessment milestones, but launch timing still depends on evidence readiness, parallel work and interruptions. Learn what the clocks actually measure.
EU MDR
Clinical evaluation: connect the claim to the evidence
A coherent device story starts before the clinical evaluation report is written.