Medical Device Management Systems

ISO 13485:2016 Awareness Training Course

Based on Medical Device Management Systems

Based on Medical Device Management Systems

WHAT YOU’LL GAIN FROM THE ISO 13485 AWARENESS TRAINING COURSES?

  • Understand the structure, requirements, and scope of the ISO 13485:2016 standard
  • Ensure an efficient and successful medical device quality management system transition to improve and maintain compliance
  • Recognise the value of ISO 13485 certification and how it contributes to medical device quality and regulatory compliance
  • Learn about quality management principles and their use in the medical devices sector
  • Learn practical methods for risk management, process validation, and documentation in the context of ISO 13485
  • Understand the basics of maintaining product quality and safety, navigating supplier management, traceability, and post-market surveillance for medical devices
  • Stay informed on the most recent innovations, and regulatory changes affecting the medical devices sector

ABOUT THE ISO 13485 AWARENESS TRAINING COURSE

The ISO 13485:2016 Medical Device Management System Awareness training course is an informative gateway for candidates interested in working in the medical devices industry. This course sets professionals apart with its unique features, where participants can learn the purpose and benefits of the ISO 13485 QMS for medical device and thoroughly understand and appreciate the requirements for the standard.

TRAINING DURATION

2-day instructor-led training

WHO SHOULD ATTEND

This course is specially designed for:

  • Medical Device Manufacturers
  • Quality and Regulatory Professionals in medical device manufacturing
  • Management Representatives and Consultants
  • Founders/CEOs of medical device companies
  • Product Developers/product designers, engineers and testing personnel
  • Quality Managers and Quality Associates in medical device manufacturing
  • Personnel, Contractors, Subcontractors
  • Material Suppliers
  • Medical Device Service Providers, including maintenance workers/validation teams
  • Purchasing teams and Operational team members
  • Medical device software designers and software update support personnel
  • QMS documentation specialists

EXAMINATION & CERTIFICATION

Upon successful completion of the ISO 13485 awareness certification course, you will receive a certificate of completion. This document attests that you have met the requirements and demonstrated competence in ISO 13485:2016 awareness. This certification adds credibility to your knowledge and skills, demonstrating to employers and clients that you have a solid understanding of ISO 13485:2016.


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