ICMED 13485 Issue 2 Medical Devices Quality Management System (MDQMS) - Awareness Course

Description

ICMED 13485 scheme is intended to enhance patient safety, and provide enhanced consumer protection along with much needed product credentials to manufacturers for instilling confidence among buyers. ICMED 13485 certification intends to significantly eliminate trading of sub-standard products or devices of doubtful origins in the market. ICMED 13485 certification also aims to bring down the substantial time and cost-run to obtain globally accepted quality certification for companies. ICMED 13485 standards is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. ICMED 13485 Foundations course teaches you the process approach, quality management principles and the requirements and benefits of ICMED 13485. The essential objective of ICMED 13485 foundations course is to create awareness for participants regarding various basic requirements of the ICMED 13485 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 ICMED 13485 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 ICMED 13485 standard
• Learn importance and benefits of an ICMED 13485 quality management system
• Understand key requirements, terms and definitions of ICMED 13485
• Understand main concepts such as risk-based thinking, process approach, Plan-Do-Check-Act, and quality management principles.
• Prepare yourself to participate in ICMED 13485 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 ICMED 13485 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.