Medical Devices

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

Imen HAMDOUNI

Toxicologist

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