Medical Devices
As a legal manufacturer of Medical Devices or as a Supplier for Medical Device manufacturing, you may have to face unexpected challenges in applying the new quality and regulatory requirements. With over 20 years of combined experience, our passionate team has extensive knowledge in all aspects that will help you succeed in your market access strategy. As your secure and reliable partner, CEHTRA can provide a comprehensive service as well as a tailor-made solution to answer your questions. We apply a tailored benefit/risk approach relevant to your product categorization and class.
Our expertise includes the Devices without an intended purpose, the borderline products, the combination products containing blood derivative, animal tissue, ancillary medicinal substance.
Meet our expert
Gaëlle REGUER
Head of Medical Devices
Key Services
Regulatory
Affairs
Support
Quality
System
Support
Product- focused
Manufacturing
process-focused
to ensure Business Performance through the whole lifecycle of technical files, from initiation to MDR/IVDR remediation
to ensure Regulatory compliance based on the ISO 13485 requirements
to ensure Patient / User-oriented Safety and Performance of the Medical Devices
to ensure consistent Quality of Products which are made available to the market
Regulatory Affairs support
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to ensure Business Performance through the whole lifecycle of Products technical files, from Design initiation to MDR/IVDR remediation
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Strategic approach of new markets
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Implementation of new requirements: EU MDR & IVDR:
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Technical files: compliance with multiple requirements
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Risk Management file: whole lifecycle, process approaches
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Standard management: technical watch, implementation in the compliance to the Essential Requirements / General Safety and Performance Requirements
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Medical Device - Vigilance Management
Quality support
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to ensure Regulatory compliance based on the ISO 13485 Standard requirements
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ISO 13485, ISO 17025, FDA 21 CFR part 820, RCD 16
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Audits: Internal & Suppliers/CMO/CRO
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Process: Creation, implementation, maintenance & reporting, risk-based approach
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Documentation: implementation, improvement for clarity & simplification
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CAPA: management at department levels
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Audit / inspections: technical support
Product-focused
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to ensure user-oriented Safety and Performance of the Medical Devices
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Preclinical Affairs: Risk assessment and control, toxicological risk assessment with skilled toxicologists
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Clinical Affairs: Clinical Evaluation Plan and Reports, Clinical evaluation of PMS & PSUR
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Clinical Trials, PMCF studies: Regulatory support for Clinical Trials
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Design transfer: From Product Specifications to Manufacturing Process
Manufacturing Process-focused
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to ensure consistent Quality of Products on the market
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Qualification & Validation strategies consistent with production requirements, training and documentation
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Qualification : Equipment & Software / process validation & verification Risk based approach
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Qualification & Validation Output for Quality Assurance
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Documentation: implementation, improvement for clarity & simplification for regulatory purpose
Value-added Services
Holistic and transversal approach
Data and bibliographic analysis for Biological Safety & Clinical Safety and Performance
Training : Regulatory Affairs, Biological Safety
Expert review of Technical Files
Responsible Person for Regulatory Compliance
Benefit/risk Evaluation
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