Quality Performance Improvement
This training is designed to provide manufacturer who wanted to register their product with MDA with specific requirement for medical device QMS to meet regulatory requirements.
ISO13485 is a requirement specific to medical device QMS for regulatory compliance purpose. It is one of the most critical certification standard for manufacturer who wanted to register their product with MDA. Suppliers / vendor to relevant manufacturer might be requested to obtain such certification as well.
This one-day introductory course will provide participant a broad understanding of the ISO 13485:2016 requirements.
This course is highly interactive with lively debate and in-class discussion, real life examples, and exercises.
By the end of the training, participants would be able to:
- Understand the basic knowledge about Medical Device QMS
- Understand the interpretation of ISO 13485 requirement
- Understand concept of medical device risk management
- Implementation of Medical Device QMS planning and strategy
1 day (9.00am to 5.00pm) or duration proposed at quotation.
Training session includes classroom lecture, exercises, group work and discussion.
Medical Device manufacturers, and suppliers to the Medical Devices industry including:
- Members of the senior management team
- Regulatory Affairs managers
- Regulatory Affairs officers
- Quality Assurance professionals
- Quality Assurance officers
- Development engineers
- Operations Managers
- Technical Sales & Marketing professionals
- Overview of Medical Device QMS
- ISO 13485 standard requirement review and interpretation
- Risk Assessment
- Regulatory Requirement and Compliance
- Planning of Medical Device QMS
- Implementation, Review and Improvement
- Use of ISO 14969 and ISO 14971 for more effective implementation
- Integration with QMS ISO 9001
- Development and implementation plan to achieve certification
- Question and answer
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.