Medical Devices

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

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