Help Clients Navigate EU In Vitro Diagnostic (IVD) & Medical Device (MD) Regulations
Accelerate EU Time-to-Trial & Time-to-Market
-
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 IVD & MD Manufacturers
- Local liaison to National Competent Authority(ies) (NCAs) & Notified Body(ies) (NBs)
- 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
- Technical experts prepare Annex XIV documentation
- Authorized Representative
- Represent manufacturer
- Support Single Registration Number (SRD) & UDI-DI assignments
- Secure Document Storage
- Manage Structured Dialogue Meetings with NBs
- Manage Performance Evaluation Studies (Regulatory & Clinical Operations Team)
- Provide documentation to qualify Boudicca DX™ as a EU IVDR & MDR subcontractor
- Manage CE-marking for clients
- Manage Notified Body Interactions
- Postmarket Surveillance Support to monitor product safety & recalls
- EU & US Boudicca DX™ employees work closely together to streamline & harmonize global submissions reducing costs & timelines
EU MDR and IVDR Compliance Support
- Dedicated EU regulatory experts streamlining EU regulatory processes
- Product Classification Support
- MDR Class I, Class IIa, Class IIb, & Class III
- IVDR Class A, Class B, Class C, & Class D
- Product Classification Support
- PhD-trained scientists with validation experience to manage & review Technical File Documentation to ensure it provides sufficient 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 (e.g., US laboratories) with compliance
- Manage document translations when required (Clinical Operations Team)
Unparalleled Companion Diagnostics (CDx) Expertise
- 15+ years of EU CDx experience (experienced the IVDD > IVDR transition)
- Drug development experience so no learning curve required, reducing timelines
- Review Biopharma clinical protocols <24 hr to quickly identify EU IVDR compliance requirements
- Describe clinical biomarker testing appropriately in Clinical Trial Applications (CTAs), e.g., Investigational Medicinal Product Dossier (IMPD) to mitigate clinical holds and reduce Requests for Information (RFIs)
- Generate EU IVDR clinical performance study documentation & manage submissions to the NCAs (experience with Belgium, Denmark, France, Germany, Ireland, Italy, Netherlands & Spain)
- Manage Ethics Committee (EC) submissions
- Extensive experience leveraging local comprehensive genomics profiling (CGP) and genetics testing for eligibility
- Extensive experience leveraging Article 5(5) health institution exemption status & support Biopharma with in-house test (IHT) set-up & compliance
- Support clinical biomarker testing decentralization to enable Biopharma to use best-in-class and first-in-class technology for their clinical trials rather than settling for mediocre technology in one CRO laboratory
- Continuous intelligence from supporting 90+ global clinical trials & attending EMA and NCA Scientific Advice Meetings with Biopharma clients
- Support EMA CDx discussions
- Independent CDx biomarker data monitoring (Clinical Operations)
- Extensive global CDx clinical bridging study experience
- Currently support global studies with patients in China, EU, Japan, & US clinical trials to support EMA, FDA, & PMDA marketing authorisation filings
- Currently support studies leveraging global clinical trials for rare biomarkers & diseases
- Support performance evaluation notifications for leftover specimens
- Knowledgeable on the importance of ascertainment rates & global regulator expectations
- Biostatistician supports negative sampling strategies, sensitivity analyses, imputation & missing data handling in accordance with current regulatory expectations
- Drug development experience so no learning curve required, reducing timelines
EU IVDR & MDR Quality Compliance Expertise & Auditing
Knowledgeable in:
- ISO 13485 Medical Devices Quality Management System
- ISO 9001 Quality Management Systems
- ISO 20916 Clinical Performance Studies
- ISO 14971 Risk Management
- ISO 14155 Clinical investigation of medical devices for human subjects GCP
- 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
- ISO 19011 Auditing Management Systems
- 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
- Electrical safety & electromagnetic compatibility
- Mechanical & Thermal Risks
- GCP
- Implementation & Audits
- Apply Quality by Design (QbD)
Global End-to-End Solution
- Support clinical trials to commercial launch in the EU
- Support global harmonization working in tandem with US Boudicca DX™ personnel to leverage all existing clinical & technical documentation to the maximum extent
- Save time & money with elimination of additional third parties to support EU & US regulatory submissions & reduce global disharmonisation, keeping budgets & timelines as minimal as possible
