EU MDR Consulting for Medical Device Software Compliance
Achieve EU MDR 2017/745 Compliance with Confidence
Ensure your medical device software meets the full scope of EU MDR 2017/745 regulation requirements.
QMLogic provides expert EU MDR consulting services, guiding you from gap analysis and documentation to CE certification and post-market activities.
Our EU MDR Consulting Services
EU MDR 2017/745 Gap Analysis & Compliance Strategy
We evaluate your product’s current regulatory position and develop a clear path to EU MDR compliance:
- In-depth gap analysis against EU MDR 2017/745
- Review of existing documentation and risk files
- Strategic plan tailored to classification and conformity assessment
Technical Documentation & Clinical Evaluation
Build audit-ready technical documentation aligned with MDR Annex II and III:
- Authoring and optimization of technical files
- Clinical Evaluation Reports (CERs) and performance evidence
- Alignment with ISO 13485 QMS and ISO 14971 risk management
EU MDR Classification & Conformity Assessment
Determine the correct classification of your software and plan your certification route:
- Analysis based on EU MDR classification rules
- Definition of conformity assessment pathway
- Support for CE marking and engagement with Notified Bodies
Post-Market Surveillance (PMS) & Vigilance
We help you implement effective PMS and vigilance systems:
- PMS planning and reporting aligned with MDR Articles 83–86
- Tools for trend analysis, vigilance reporting, and corrective actions
- Integration with lifecycle risk management and feedback loops
EU MDR Training & Team Enablement
Equip your team with the knowledge to sustain compliance:
- Targeted EU MDR training for product, RA, QA, and leadership teams
- Live or remote workshops on technical, clinical, and regulatory topics
- Ongoing advisory support through product lifecycle
Why Choose QMLogic as Your EU MDR Consultant?
Our team combines deep expertise in MDR Regulatory Affairs with hands-on experience guiding software and digital health products through EU MDR compliance, CE certification, and long-term audit readiness.
EU MDR Expertise for SaMD & Digital Health
We specialize in EU MDR consulting for software and connected devices, including:
- Standalone SaMD (Software as a Medical Device)
- Embedded medical software and integrated platforms
- Cloud-based and AI-driven digital health applications
Experience with CE Certification & Audit Readiness
We have successfully guided multiple products through:
- CE certification audits under EU MDR 2017/745
- Gap closures based on Notified Body feedback
- Surveillance audits and long-term compliance support
Seamless Integration with Your QMS & Tools
We design MDR compliance strategies that align with your existing systems:
- QMS per ISO 13485 and risk frameworks per ISO 14971
- Hands-on experience with Jira, Confluence, SharePoint, and Power Platform
- Integrated documentation and collaboration workflows
MDR Regulatory Affairs – Navigating Compliance with Confidence
Who Must Comply?
EU MDR 2017/745 applies to all manufacturers of medical devices and software intended for medical use in the EU, including:
- Standalone diagnostic or therapeutic software
- Software embedded in medical devices
- Apps and cloud platforms processing medical data
Why EU MDR Compliance Matters
EU MDR certification isn’t just mandatory — it protects your product, patients, and brand:
- Ensures CE marking and legal EU market access
- Confirms performance and safety through clinical evidence
- Builds confidence with users, regulators, and partners
- Avoids costly delays, rejections, or post-market penalties
Additional EU MDR Consulting Services
- EU MDR 2017/745 Gap Analysis
- Technical Documentation Development
- EU MDR Classification Strategy
- Clinical Evaluation Support
- Post-Market Surveillance (PMS) & Vigilance System Setup
- MDR Regulatory Affairs Consulting
- EU MDR Training & Team Workshops
- CE Certification Preparation
- Long-Term Lifecycle Compliance