Medical device

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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

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

NORMATIVE ENVIRONMENT

  • DIRECTIVE 93/42/CEE
  • DIRECTIVE 98/79/CE
  • ISO 13485