Quality Management for Medical Devices: ISO 13485 Training Course

Module 1: The background and history of QMS and the need for a QMS, the advantages and benefits and embracing a quality culture earlier on in the business.
We will look at the reasons for the need for a QMS and the history of how ISO 13485 has evolved and the need to take this on early in your company.

Module 2: Clause 4 Quality Management System
We will look at the Quality Manual, control of documents, control of records, and the medical device file.

Module 3: Clause 5 Management Responsibility
We will explore the Quality Policy and its connection to the Quality Objectives. Additionally, we will discuss the significance of management commitment, the necessity of defining responsibilities and authorities, and the requirements for management review meetings.

Module 4: Clause 6 Resource Management
We will review human resource needs, work environment, contamination control, and infrastructure of your device.

Module 5: Clause 7 Product Realisation
We will discuss the requirements for your product, planning the development, design inputs, outputs, design reviews, verification, validation, design transfer, design changes and when to notify the authorities, and the creation of a design file. We will also look at the key differences between US DHF (Design History File) and EU TF (Technical File). We will also look at purchasing needs, supplier evaluation and production requirements

Module 6: Clause 8 Measurement, analysis and improvement.
We will discuss feedback, complaints, Post Market surveillance, Internal Audits. Equipment calibration and maintenance. Vigilance reporting and obligations to regulatory authorities. We will also look at Corrective action and Preventive action (CAPA).

Module 7: A suggested structure of your QMS & Actual application of ISO 13485 in your business
We will provide you with a suggested structure for your product needs. We will discuss how ISO 13485 is best applied in your business based on your product complexity, resources, and organisation needs.

Module 8: The audit process and what to expect – Stage 1 and Stage 2 and Recertification, surveillance and keeping your QMS alive and also eQMS vs paper.
We will provide you with a suggested structure for your product needs. We will discuss how ISO 13485 is best applied in your business based on your product complexity, resources, and organisation needs.