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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

gaelle.reguer@cehtra.com

Imen HAMDOUNI

Toxicologist

imen.hamdouni@cehtra.com

Key Services

Regulatory

Affairs

Support

Quality

System

Support

Quality

System

Support

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

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

  • Strategic approach of new markets

  • Implementation of new requirements: EU MDR & IVDR:

  • Technical files:  compliance with multiple requirements

  • Risk Management file: whole lifecycle, process approaches

  • Standard management: technical watch, implementation in the compliance to the Essential Requirements / General Safety and Performance Requirements

  • Medical Device - Vigilance Management

Quality support

  • to ensure Regulatory compliance based on the ISO 13485 Standard 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 / inspections: technical support

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 Plan and Reports, Clinical evaluation of PMS & PSUR

  • Clinical Trials, PMCF studies: Regulatory support for Clinical Trials

  • Design transfer: From Product Specifications to Manufacturing Process

 

Manufacturing Process-focused

  • to ensure consistent Quality of Products on 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

Imen HAMDOUNI

Toxicologist

imen.hamdouni@cehtra.com

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