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Understanding ISO 13485:2016

Course summary
7 weeks
Full time
Online courses
Professional Training

Course description

Understanding ISO 13485:2016

The publication of ISO 13485:2016 marked a turning point in Quality Management Systems for those involved in the life-cycles of medical devices in the EU. The deadline for compliance was March 2019, however in addition to this, the FDA have recently announced their plans to harmonise their Quality System regulations under the Medical Device Single Audit Programme (MDSAP) with ISO 13485:2016, so organisations under the FDA meet both domestic and international requirements.

This essential 7 module course will allow you to understand the increased requirements around risk management under the 2016 revision and to familiarise yourself completely with ISO 13485:2016. In addition, participants will gain practical knowledge and key skills in conducting audits under ISO 13485 in conjunction with the most recent MDSAP auditing model, complemented with real-life case studies.

Suitability - Who should attend?

This course will be useful for anyone considering the application of ISO 13485:2016, or who needs an overview of Quality Management Systems for medical devices.  It will be applicable for professions in:

  • Quality
  • Engineering
  • Product design
  • Regulatory affairs

Training Course Content

  • Understand the documentation structure required by the standard
  • Investigate best practice for document control
  • Examine management responsibility and resource management requirements
  • Explore product realisation from the design process to manufacturing
  • Understand validation of aspects of the manufacturing process
  • Comprehend business monitoring
  • Gather and analyse data using internal audits and corrective action processes

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About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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