ISO 13485: 2012 for the MEDICAL DEVICE INDUSTRY (BS EN ISO 13485 :2012)

INTRODUCTION TO ISO 13485:2012 QUALITY STANDARD FOR THE MEDICAL DEVICE INDUSTRY
Provides a detailed overview of the Standard and the process approach to managing a company's quality system, its control and effectiveness. (BE120)

INTRODUCTION TO FDA QUALITY SYSTEM REGULATION (QSR) FOR MEDICAL DEVICES, CGMP 21 CFR Part 820
Carefully examines the requirements of the Quality Systems Regulations (QSR) and product safety, compares the requirements of QSR with MDD/IVDD, prepares companies for the design requirement, and provides the methods for successful implementation of the regulations. (BE121)

UNDERSTANDING THE EUROPEAN DIRECTIVE 93/42/EEC concerning Medical Devices
This Directive provides the 'rules of the game' in manufacturing CE marked medical devices and it is important that these are understood by all Medical Device Manufacturers. Regulatory Bodies and their roles are defined in the Directive, together with classification criteria and the routes to the EC Declaration of Conformity and the use of the CE mark. (BE124)

INTRODUCTION TO ISO 15189:2012 MEDICAL LABORATORIES
Designed to highlight the specific requirements of ISO 15189 over and above those of ISO/IEC 17025, focusing on the quality and competence requirements applicable to medical laboratories. (BE108)

RISK ANALYSIS FOR MEDICAL DEVICES
Provides understanding of the risk analysis standard for medical devices, ISO 14791, and how to use it. (BE123(i))

RISK ANALYSIS/FMEA FOR MEDICAL DEVICES
Provides understanding of risk analysis and how it applies to medical devices; develops the skills necessary to apply risk analysis methodologies, such as FMEA, to medical devices. (BE123(ii))

BS EN 62366 USABILITY ENGINEERING FOR MEDICAL DEVICES
The Usability Engineering workshop will develop the skills necessary to apply the usability engineering methodology in BS EN 62366. Delegates will be able to extend the scope of their current risk management activities for medical devices to ensure the user interface is safe and effective. (BE126)

INTERNAL AUDITOR TRAINING FOR THE MEDICAL DEVICE INDUSTRY
Complying with FDA and CE Marking Requirements (ISO 13485/9000 and QSR)
Introduces auditing as a powerful management tool in establishing an organization's effectiveness in controlling the quality variable, and discusses certification audits so the organisation can begin preparation for FDA/Notified Body audits. (BE122)

IMPROVEMENT
where you are responsible for identifying business improvement opportunities and implementing continuous improvement processes

THE PROCESS APPROACH - From Procedure to Integrated Process via Process Mapping
Focuses on how to restructure an existing procedure-based management system (eg. ISO 9001/ISO 14001) into a 'process-based' system and undertake the transition to a 'process' approach. (BE47)

SOLVING PROBLEMS USING ROOT CAUSE ANALYSIS (RCA) AND 8D/G8D
Problem solving is an essential part of the continuous improvement process, allowing companies to remove waste and improve productivity throughout the organisation. (BE45)