Implementing an ISO 13485 Quality Management System for Medical Devices

For customers needing affordable guidance on the implementation of ISO 13485. The book will provide the reader with the appropriate background information and guidance for them to confidently tackle an implementation project or review project against the requirements of the medical device quality management system requirements. The guidance will be practically based and draws on the author's considerable experience of assessing hundreds of medical device manufacturer processes. It specifically addresses the difficulties of implementing the standard. It will introduce the user to processes and, more specifically, the core processes and what enhancements are required in order to successfully implement to the degree whereby a notified body, regulator or customer are satisfied that the system fulfils requirements. Good practice will be illustrated with case studies and examples of best practice. Elements of world-wide regulatory requirements will be featured, in order for the common denominator of the process to be understood and the impact of the worldwide regulations on that process.

Table of Contents:
Implementation project planning and medical device regulatory pathways; presenting to and influencing senior management; budgeting for implementation and certification assessment; allocation of specific roles and responsibilities (regulatory defined requirements); process identification (typical medical device processes); process design and documentation; (the Plan, Do, Check and Act process); standard operating procedures, work instructions and document process control; developing development documentation (design history records); developing technical documentation and the device master record; developing testing processes and documentation; designing and implementing a risk management framework; documenting risk management; quality planning and its relevance to medical device regulations; designing and implementing a communication and process interaction framework; developing the quality manual; manufacturing control process and documentation (the batch history record); supplier selection, control and evaluation process and documentation; purchasing information and supplier agreements; the validation process and basic documentation; customer-related processes including sales, enquiries and complaints management; post-market surveillance frameword and documentation; vigilance and investigation processes; advisory notifications; data analysis and the management review process; planning improvements and objectives; maintenance and facilities processes and documentation; cleaning process and clean room controls; conducting a regulatory and medical device management system gap analysis; the audit process (basic).