Our training sessions include presentation, exercise, case study, workshop, handouts, reference documentation or use of relevant database when applicable. The instructors are experienced and subject matter experts.
Here is the catalog of training we are currently proposing
FDA cGMP Quality system conformity to CFR21-Part820 - 1 Day
What will you learn during this training class:
Market Clearance: Classification of the medical devices, registration and listing, 510(k) and PMA
Quality System Regulation (QSR): Management, Design Control, Process Control, Inspection and Testing, Product Control, Monitoring and Feedback, Documents and Records, Other Requirements
Comparison between requirements of the ISO 13485 and the QSR
FDA Quality System Inspection Techniques (QSIT): Management, Design Control, Corrective and Preventive Actions, Production and Process Control
FDA 510k submission - 2 Days
What will you learn during this training class:
History and presentation of the FDA
Classification of medical devices in the USA, Premarket Notification / Premarket Application
510(k) procedure: to which Medical Device is it Applicable? General Principle of the 510(k), substantial equivalence, 510(k) Requirements for Federal Food, Drug and Cosmetic Act
510(k) File: Key elements of the file, descriptive/regulatory/performance data, Methodology, File Submission Procedure to FDA
Directive 2007/47/CE amendment of the European Regulation of Medical Devices - 1 Day
What will you learn during this training class:
Background of the amendment of the directives 93/42/EEC and 90/385/EEC
Overview of the major changes
Essential Requirements
Classification
Conformity Route
Clinical Data and Post-market clinical follow-up
Manufacturers, Competent Authorities, Notified Bodies: evolution of the roles and responsibilities
European Regulation of Medical Devices - 1 Day
What will you learn during this training class:
Regulatory Background and applicable regulation
Definition of a medical Device
Classification
Key Player of the regulatory process: Manufacturer, Notified Body, Competent Authority, Users
Essential Requirements
Harmonized Standards
Modes of establishing the CE marking, Compliance Route
Technical File: Content and Purpose
Vigilance Activities
ISO 13485 - 2 Days
What will you learn during this training class:
Background of the ISO 13485 standard: internationnal and european status, link with the different regulations
Process Approach: definition of the concept, objective, benefit, metrics
Analysis of the requirements of the ISO 13485
Risk Management Process ISO 14971
ISO 9001 - 1 Day
What will you learn during this training class:
Background of the ISO 9001 standard
Process Approach: definition of the concept, objective, benefit, metrics
Analysis of the requirements of the ISO 9001
Risk Management System and ISO 14971 - 2 Days
What will you learn during this training class:
Presentation of the background of the technical documentation and its content
Introduction to ISO 14971: objectives and review of the different steps of the risk management process
Risk Management: GHTF guidance, Human Factor, Introduction to the different tools to use during risk management activities
Software Development Life Cycle - 2 Day
What will you learn during this training class:
Presentation of the regulations and the requirements linked with the development and the validation of a software
Software Development Planning
Requirements Identification: design input
Design and architecture of a software
Implementation of a risk management process for a software
Tests performed on a software
Configuration and Cybersecurity Management
Maintenance of software and problem resolution: corrective and preventive action implementation
Internal Audit and Supplier Audit - 2 Days
What will you learn during this training class:
Purpose of the internal audit and supplier audit
Presentation of the ISO 19011
Documents linked with auditing
8 Main principles for Management
Management of processes
ISO 13485 standard
Risk Management
Communication: Key Players and challenges of communication during audit, meeting during audits, factual decision making
Role Playing and Real Life Situation
If you wish to participate in one of these training please contact usfor a preliminary discussion
