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Medical Devices

As a legal manufacturer of Medical Devices or as a Supplier of components for Medical Device manufacturing, you may 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 provides a comprehensive service. We apply a tailored benefit/risk approach relevant to your product categorization and class. Our expertise includes Devices without an intended purpose, borderline products, combination products containing blood derivative, animal tissue, ancillary medicinal substance.

Meet our expert

Gaëlle REGUER

Head of Medical Devices

gaelle.reguer@cehtra.com

Key Services

Regulatory

Affairs

Support

Quality

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 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

  • to ensure Business Performance through the whole lifecycle of technical files, from initiation to MDR/IVDR remediation

  • Strategic approach of new markets

  • Implementation of new requirements: EU MDR:

  • Technical files:  compliance with multiple requirements

  • Risk Management file: whole lifecycle, whole processes

  • Standard management: technical watch, implementation in Essential Requirements

  • Comprehensive MD Vigilance

Quality support

  • to ensure Regulatory compliance based on the ISO 13485 requirements

  • ISO 13485, ISO 17025, FDA 21 CFR part 820, RCD 16

  • Audits: Internal & Suppliers/CMO/CRO

  • Process: Creation, implementation, maintenance & reporting, risk-based approach

  • Documentation: implementation, improvement for clarity & simplification

  • CAPA: management at department levels

  • Audit: technical management

Product-focused

  • to ensure user-oriented Safety and Performance of the Medical Devices

  • Preclinical Affairs: Risk assessment and control, toxicological risk assessment with skilled toxicologists

  • Clinical Affairs: Clinical Evaluation Reports, Clinical evaluation of CAPA/Complaints

  • Clinical Trials: regulatory support of Clinical trials

  • Design transfer: From Product Specifications to Manufacturing Process

 

Manufacturing Process-focused

  • to ensure consistent Quality of Products which are made available to the market

  • Qualification & Validation strategies consistent with production requirements, training and documentation

  • Qualification : Equipment & Software / process validation & verification Risk based approach

  • Qualification & Validation Output for Quality Assurance

  • 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

Downloads

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Key Contact

Gaëlle REGUER

Head of Medical Devices

gaelle.reguer@cehtra.com

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