ISO13485:2016 Training

ISO13485:2016 Training

ISO13485 is a stand-alone QMS standard, derived from the internationally recognized and accepted ISO 9000 quality management standard series.
ISO13485 is based on the ISO9001 process model concepts of Plan, Do, Check, Act, it is designed for regulatory compliance; therefore, it is more prescriptive in nature and requires a more thoroughly documented QMS.
ISO13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes.
It ensures the consistent design, development, production, installation and delivery through to disposal of medical devices that are safe for their intended purpose.
The ISO13485 Training is an effective solution to meet the comprehensive requirements for a QMS.
Adopting ISO13485 provides a practical foundation for manufacturers to address the regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
ISO13485 is an international standard that specifies requirements for quality management systems for the medical device manufacturing industry.
URS’s ISO13485 training courses can help any organization involved in the design, production, installation, and servicing of medical devices understand and apply quality management standards.