Medical device

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

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

Twoksa Website

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