Boudicca DX™ EU Operations
EU Subsidiary in Ireland
Support Global Clients Navigating EU In Vitro Diagnostic and Medical Device Regulations
Accelerate EU Time-to-Trial & Time-to-Market & Harmonize with US & Rest of World Regulatory Strategy & Submissions
-
BOUDICCA DX LIMITED
Ireland CRO Registration Number: 779741
Registered Address
6th Floor, 2 Grand Canal Square
Dublin 2, Ireland, D02 A342
Trading Address
Pavilion House, 31 Fitzwilliam Square
Dublin 2, Ireland
Limerick Office Opening June 2025!
Boudicca DX™ EU Consulting Services
EU Representation for In Vitro Diagnostics (IVDs) & Medical Devices (MDs) Manufacturers
- EU local liaison providing timely communication and proactive responses to National Competent Authority(ies) (NCAs) & Notified Body(ies) (NBs)
- EU Legal Representative for Clinical Performance Studies
- Ensure compliance with the Sponsor’s obligations
- Point of Contact for communications between the sponsor and the NCA
- Submit and manage documentation required by NCA
- Prepare Annex XIV documentation
- EU Authorized Representative
- Represent manufacturer
- Support Single Registration Number (SRD) & UDI-DI assignments
- Secure Document Storage
- Manage Structured Dialogue Meetings with Notified Bodies (application process, assessment procedures, QMS requirements, conformity approaches, technical & regulatory approaches, etc.)
- Manage Performance Evaluation Studies (Regulatory & Clinical Operations)
- Provide documentation to qualify Boudicca DX™ as a consulting subcontractor
- Manage CE-marking for clients in compliance with EU IVDR & MDR
- Manage Notified Body Interactions
- Postmarket Surveillance Support to monitor product safety & recalls
- EU & US Boudicca DX™ team members work closely to to streamline & harmonize global submissions
EU MDR and IVDR Compliance Support
- Dedicated EU regulatory experts streamlining EU regulatory processes
- Product Classification Support
- MDR Class I, Class IIa, Class IIb, and Class III
- IVDR Class A, Class B, Class C, and Class D
- Product Classification Support
- PhD-trained scientists with assay development experience to manage & review Technical File Documentation to ensure it provides objective evidence for compliance
- Ensure analytical & clinical performance data support the intended use to reduce time to Certificate Decision & number of RFIs
- Generate & review Intended Purpose statements
- Manage State-of-the-art (SOTA) analysis
- Experts in CLSI Guidelines & ISO standards
- Scientific Literature Reviews
- Generate Summary of Technical Documentation
- Generate Summary of Safety and Performance
- Labeling generation & review
- Medical Writers manage publishing of Technical File Documentation (Parts A through K) in accordance with Notified Body Expectations
- Assessment of Conformity with EU IVDR & MDR procedures
- Boudicca DX™ General Safety and Performance Requirements (GSPR) Template
- Use to demonstrate conformity with relevant requirements
- Audit Technical File Documentation using Boudicca DX™ Completeness Checklists
- Support EU Reference Laboratory (EURL) Performance Verifications if required
- Support distance sales clients with compliance
- Manage document translations when required (Clinical Operations Team)
Companion Diagnostics (CDx)
- 15+ years of EU Companion Diagnostics experience (IVDD & IVDR)
- Support Biotech & Pharma companies with clinical trial assay requirements
- Support EU IVDR clinical performance studies (documentation & submissions)
- Support health institution exemption Article 5(5) status compliance
- Continuous intelligence supporting clinical trials & Scientific Advice Meetings
- Support EMA CDx discussions & Notified Body Consultations
- Independent CDx data monitoring (Clinical Operations Team)
EU IVDR & MDR Quality Compliance & Auditing
- ISO 13485 Medical Devices Quality Management System
- ISO 20916 Clinical Performance Studies
- ISO 9001 Quality Management Systems
- ISO 14971 Risk Management
- ISO 15189 Medical Laboratories Requirements
- ISO 27001 Information security, cybersecurity and privacy protection
- ISO 42001 Artificial Intelligence Management System (AIMS)
- IEC 62304 Software Life Cycle Process
- Support Software Development Plans, Requirements Analysis, Architectural Design, Unit Implementation, Verification, Integration Testing, Systems Testing, Release & Risk Assessment
- AI/ML Risk Management, Train-Test-Deploy Documentation, AI/ML Requirements, Verification & Validation
- ISO 19011 Auditing Management Systems
- Electrical safety & electromagnetic compatibility
- Mechanical & Thermal Risks
- GCP
- Implementation & Audits
End-to-End Solution
- Support registration to launch in the EU
- Support global harmonization working in tandem with US Boudicca DX™ team to leverage all existing clinical & technical documentation to the maximum extent, e.g., global clinical bridging studies
- Save time & money with elimination of additional third parties to support EU & US regulatory submissions & reduce global disharmonisation, keeping budgets & timelines minimal
