Medical Device Regulatory Services
Complete regulatory support for medical devices and IVDs under EU MDR and IVDR from concept to CE marking and beyond
Our Medical Device Services
MDR/IVDR Compliance & CE Marking
Complete regulatory pathway support for EU market access
- Device classification and regulatory strategy
- Technical documentation preparation
- CE marking conformity assessment
- Declaration of Conformity preparation
Quality Management Systems
ISO 13485 implementation and maintenance for medical device manufacturers
- ISO 13485:2016 QMS design and implementation
- Quality manual and procedure development
- Internal audit programs
- Management review and CAPA systems
Risk Management - ISO 14971
Comprehensive risk management throughout device lifecycle
- Risk management plan development
- Risk analysis and evaluation (FMEA, FTA)
- Risk control measures implementation
- Post-production risk monitoring
Clinical Evaluation & Investigation
Clinical evidence generation and evaluation per MDR/IVDR requirements
- Clinical Evaluation Reports (CER)
- Clinical Investigation Plans - ISO 14155
- Literature reviews and equivalence assessments
- PMCF (Post-Market Clinical Follow-up) studies
Notified Body Liaison
Expert support for Notified Body interactions and submissions
- Notified Body selection and engagement
- Submission preparation and review
- Audit preparation and support
- Certificate maintenance and renewals
Post-Market Surveillance & Vigilance
Ongoing compliance and safety monitoring post-market
- PMS (Post-Market Surveillance) plan and reports
- PMCF and PMPF study design and execution
- Incident reporting and FSCA management
- Periodic Safety Update Reports (PSUR)
EU Medical Device Regulatory Framework
Our services ensure full compliance with European medical device regulations and international standards.
Compliant
Experience Across All Device Classes
Low Risk Devices
Self-certification support with technical documentation and declaration of conformity
Medium-Low Risk
Notified Body assessment with comprehensive technical files and clinical evaluation
Medium-High Risk
Enhanced Notified Body review including design dossier and clinical data
High Risk Devices
Full conformity assessment with extensive clinical investigation and ongoing surveillance
Our Medical Device Regulatory Process
Classification & Strategy
Device classification and regulatory pathway determination
QMS Implementation
ISO 13485 quality management system setup
Technical Documentation
Complete technical file or design dossier preparation
Clinical Evidence
Clinical evaluation and investigation as required
Conformity Assessment
Notified Body submission and CE marking
Post-Market Activities
Ongoing surveillance, vigilance, and compliance
Device Categories We Support
Active Implantable Devices
Pacemakers, neurostimulators, drug pumps
Diagnostic Devices
Imaging systems, monitoring equipment, IVDs
Surgical Instruments
Powered surgical tools, implants, accessories
Therapeutic Devices
Infusion systems, respiratory devices, dialysis
Software & Digital Health
SaMD, mobile health apps, AI/ML devices
Combination Products
Drug-device, biologic-device combinations
Navigate Medical Device Regulations with Confidence
Partner with our medical device regulatory experts for successful EU market access