ISO 13485 2016 Medical devices — Quality Management System — Requirements for Regulatory Purposes - Awareness Course

Description

Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes ISO 13485 2016 Foundations course teaches you the process approach, quality management principles and the requirements and benefits of ISO 13485 2016. The essential objective of ISO 13485 2016 foundations course is to create awareness for participants regarding various basic requirements of the ISO 13485 2016 standard & impart working knowledge on how these requirements can be interpreted to suit the organization’s processes, products, people & customers.

Who Should Attend?

• Anyone involved in the planning, implementing, maintaining, supervising or auditing of an ISO 13485 2016 medical device quality management systems
• Jobseekers interested in understanding the best quality management practices followed by the organizations in the medical device value chain
• Anyone looking to gain skills and knowledge in medical device quality management system

Key Benefits

• Understand the structure of ISO 13485 2016 standard
• Learn importance and benefits of an ISO 13485 2016 quality management system
• Understand key requirements, terms and definitions of ISO 13485 2016
• Understand main concepts such as risk-based thinking, process approach, Plan-Do-Check-Act, and quality management principles.
• Prepare yourself to participate in ISO 13485 2016 standards implementation process
• Manage quality and drive continual improvement
• Take steps to ensure that quality is at the heart of your organization
• Attract and retain customers by meeting their current and future needs better
• Understand documents and records relevant to ISO 13485 2016 quality management system , critical to the products and services delivered and those required to meet customer and regulatory requirements
• Fill gaps in your professional knowledge

Learning & Evaluation Method

This is  a live and interactive course.  Once you purchase the course, our team will contact you to plan the training. No matter where you are located, we schedule the classes based on your convenience and time zone. You can plan to attend the training in sessions of 4 or 8 hr duration, based on how much time you can spend in a day.

Buy for group Are you planning to buy this course for a group? We have the best prices for you! Select ‘Buy for Group’ option and add to the cart. You will get a discount of 60 – 75% for a group of up to 10 participants. To make a group purchase, create your group name and add individual emails of up to 10 participants. Each participant will get the access to the course materials, exam and the certificate. We will arrange one live-online session for the entire group.