ISO 13485 part 2

Service Description

Part 2 The aim of this training is to understand the requirements of a quality management system in accordance with the NF EN ISO 13485 standard, particularly regarding quality policy, the process approach and quality indicators, so that the quality management system complies with this standard. Identify and justify the required infrastructure by proposing the use of the Atlassian suite (Jira, Confluence, Bitbucket, Xray, Document Manager for Confluence DMC, Comala, SoftComply). Target audience: Medical device industry professionals, including manufacturers, distributors and service providers. Persons responsible for regulatory compliance of medical devices (PRRC), quality managers, internal auditors and any team member involved in medical device quality management. Project managers and members of the management team responsible for implementing a QMS compliant with the NF EN ISO 13485 standard. Engineers, software developers, product designers and other professionals involved in the medical device design process. Training program: Module 1: Review of the NF EN ISO 13485 standard General overview of the NF EN ISO 13485 standard. Recap of the scope and key requirements already presented in the previous training. Importance of compliance with the standard for organizations. Module 2: Product realization Purchasing management to ensure the quality of components and suppliers. Production and service provision processes compliant with specified requirements. Product control and release to ensure conformity. Management of customer-related processes to ensure satisfaction. Module 3: Measurement, analysis and improvement Handling customer complaints to resolve issues and improve satisfaction. Conducting internal audits to assess the compliance and effectiveness of the QMS. Handling non-conformities and implementing corrective and preventive actions. Using quality indicators to measure performance and make data-driven decisions. Module 4: Application Ecosystem Presentation of a Quality Management System (iQMS) using the Atlassian ecosystem, configured by our team.