Medical Devices Quality Management System - ISO 13485:2016
What you'll learn
- How ISO 13485 requirements apply to medical device companies
- Requirements of the ISO 13485:2016 standard
- The importance of implementing a Quality Management System per ISO 13485:2016
- No specific prior knowledge is required
- Familiarity with quality management systems is helpful
- A general understanding of medical device life-cycle is useful
- Owning the ISO 13485:2016 standard is optional but recommended
The ISO 13485:2016 standard specifies requirements for the Medical Device Development and Quality Management System (QMS) that should be used by medical device-related companies.
Having a proper QMS in place is essential for medical device-related companies. Global regulatory requirements emphasise this and make it mandatory for such standards to be adhered to by companies worldwide.
With this need for implementation, comes a need for understanding of the requirements.
The purpose of this course is to clarify the application of ISO 13485:2016 standards for medical device companies and development of the medical device.
In this course, we will walk through the ISO 13485:2016 standard to:
Clarify on the concepts
Show how it relates to business processes
Elaborate on the practical application
You can learn what the requirements are, and be aware of best practice guidelines that are beneficial to your operations.
Furthermore, you can begin preparing your relevant set of documents (Quality Manual, SOPs, etc) for immediate implementation of your SOPs.
Understand and implement a best-practice Quality Management System as per requirements for the medical industry.
Get the information you need to design, coordinate and improve your company's QMS as per ISO 13485:2016.
Who this course is for:
- Medical device companies looking to set up their QMS and get ISO 13485:2016 certified
- Professionals tasked with overseeing a management system meeting ISO 13485 standards
- Quality managers
- Risk managers
- Medical device practitioners interested in the ISO 13485 framework
At Stendard, we believe that quality is everyone’s business because it takes a team to consistently deliver and uphold great standards that build confidence with customers, partners and the community. We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organisation, and accelerate global growth. Our vision is to put quality at the centre of your business and make it easier.
In the past years, the team at Stendard has been internationally involved with more than 400 companies working to attain the ISO 13485, ISO 22000, ISO 27001 and many more certification standards.