ISO 13485:2016 Consulting

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

Some of the key aspects to ISO 13485:2016 include:

  • Alignment of global regulatory requirements
  • Inclusion of risk management and risk based decision making throughout the quality management system
  • Additional requirements and clarity with regard to validation, verification, and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms
  • More explicit requirements for software validation for different applications
  • Alignment of global regulatory requirements
  • Validation using pre-clinical and clinical evaluations
  • Validation of packaging and distribution requirements
  • A feedback section, including a new complaint-handling section and other guidance for customer communications
  • Additional improvement measures: adding the use of post-market surveillance, risk-based decisions, and timelines

We specialize in ISO 13485:2016 implementation assistance along with in-house or public training workshops.

The following ISO 13485:2016 workshops are now available:

  1. ISO 13485:2016 Overview
  2. ISO 13485 Lead Auditor Training
  3. ISO 13485:2016 Internal Auditor Training

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