Medical device expert center
According to its strong experience in the health field, CaduCeum provide you with its expertise concerning Clinical and Scientific Affairs (CSA) in the following fields:
Medical Devices / In Vitro Diagnostic Medical Devices / Pharmaceuticals / Cosmetics
FIELD OF COMPETENCY
- Manage all Clinical and Scientific literature project or review
- CaduCeum’s dedicated service
- Multi-disciplinary team with the requested skills (PhD, PharmD, Engineers, …)
TAILORED SERVICE
- All products ⁄ devices in health field
- Dedicated starting meeting for each project
- Regular follow-up meetings with the customer
- Writing of the final report, reviewed and validated with the customer
- Regulation’s requirements taken into account
CLINICAL & SCIENTIFIC LITERATURE
- Bibliographic research protocol establishment
- Selection of relevant articles from specialized databases
- Critical analysis and synthesis of selected articles
SERVICES
- Clinical or Performance evaluation report:
- Complete writing
- Gap analysis
- Proof of Concept (PoC)
- Protocol for Post Market Clinical Follow-up (PMCF)
- Bibliographic validation of the indication of a product
- Non Clinical and Clinical Summaries & Overviews (CTD 2.4, 2.5, 2.6, 2.7)
- Periodic Safety Update Report (PSUR)
- Articles bibliographic surveillance (according to customer’s criteria)
- Writing of articles, abstracts, posters or any kind of scientific publication
- Clinical project:
- Clinical study protocol writing and registration dossier
- Selection of investigative sites
Design Study
- Functional specifications
- Risk Analysis
Research of technical solutions
- Writing of User’s Requirement Specifications (URS)
- Writing and involvement
- Supplier approval
- Quality Control
Purchase management and suppliers
- Budget management
- Planning management
- Design monitoring
- FAT/SAT
Industrialization
- Studies/model design
- Equipment installation/premises/utilities
- Maintenance/metrology
- Maintenance task lists
- Maintenance intervention management
- Shutdown management

NORMATIVE ENVIRONMENT
- ISO 13485
- ISO 14971
Quality management system
Twoksa Website
- Quality management : ensure process compliance
- Audit and training :
- ISO 13485
- Internal audit
- Supplier audit
- …
- Determination and setting up action plans
- Inspection preparation
- Quality Product Review
- Complaint management
System Quality Assurance
Twoksa Website
- Documentation, creation, updating of procedures
- Quality system audit
- GAP Analysis – Compliance
Operational Quality Assurance
- CAPA, deviations, anomalies
- Change control management
- Investigation/ setting up action plans/ Closure
- Process monitoring
- Stability studies
Qualification / Validation
- Equipment qualification
- Machining
- Molding
- Coating
- Packaging
- Special process validation
- Cleaning
- Sterilization
- Biocompatibility

NORMATIVE ENVIRONMENT
- ISO 13485
- ISO 9001
- ISO 14001
- CFR
- PACKAGING :ISO 11607-1&2 IS
- STERILIZATION :ISO 11135 & 11137
- CLEANING : NF S 94-091
- BIOCOMPATIBILITY : ISO 10993-1
Classification & regulatory submission
- Determination of the devices’ categories
- Products’ files establishment and update
- Files’ Establishment/Renewal/ Update:
- CE marking
- 510 K
- Export (China, Japan, Mexico, …)
- Submission and taking remarks into accounts.
Conservation and regulatory renewal
- Regulatory monitoring (gap analysis)
- Risk analysis of the products
- Application of new or updated regulations
- UDI
- ISO 13485 :2016

NORMATIVE ENVIRONMENT
- DIRECTIVE 93/42/CEE
- DIRECTIVE 98/79/CE
- ISO 13485