This training is designed to provide complete guidance enabling participants to have a full understanding of control of monitoring and measuring equipment in relationship to medical device product/service realization’s day-to-day operation.
This is a customized training program that provide complete guidance enabling participants to have a full understanding of control of monitoring and measuring equipment in relationship to medical device product/service realization’s day-to-day operation. This introductory course enable participants to have a basic understanding of Risk Management for Medical Devices.
By the end of the training, participants would be able to:
- To enable participants to understand all critical requirements in the control of monitoring and measurement equipment needed to provide evidence of conformity of product (to spec/requirements) in medical devices manufacturing, as per subsection 7.6, Control of monitoring and measuring equipment in ISO 13485 standard
- To enable participants to anticipate the monitoring and measurement of product and its importance from the monitoring and measuring (equipment) standpoint
- To guide participants to effectively develop procedures to ensure monitoring and measurement (and equipment) are performed consistently with the monitoring and measurement requirements
- Enable participants to understand and react to the measurement validity in the situation of non-conformance measurement equipment
- To provide guidance, best practices and references in creating and maintaining, accurate calibration and verification records
Duration proposed at quotation.
Training session includes classroom lecture, exercises, group work and discussion.
Managers, Engineers, Supervisors, Technician of various departments: Quality Assurance, Production, Engineering, Facility, Warehouse, Purchasing, and members of the equipment and facility/utility team.
- ISO 13485, Sub-section 7.6, Control of monitoring and measuring equipment – details of the requirements
- Measurement system analysis and calibration
- Calibration Procedure: What should be in the scope – Control, Work Instructions, Schedule (list) and Monitoring (status)
- Calibrate, verify and adjustment
- Master Equipment and reference to standards and traceability
- Actual practice – ID, status, safeguarding, responsibility
- Protection from damage and deterioration during handling, maintenance and storage
- Non-conformance handling – validity of measuring results, product review and disposition
- Software used in calibration equipment – Validation Calibration records
Certificate of Attendance will be issued to participants who fully participated the training and satisfied the attendance requirements.
Why Engage aNTS / Peplow-Warren?
Peplow-Warren Consultant Team is formed by a group of experienced sector expert, certification auditors, consultants and industry practitioners. They actively involve in international standard and specifications development by acting as active ISO and MOSTI Technical Committee Member. They carry a common mission: they are willing to share their good knowledge with current industry practitioners. Call us today for more detail. We are obliged to work together and grow your business.