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Understanding ISO 13485:2016 and the Medical Device Single Audit Programme

7 weeks - 1 hour per week

2 March - 24 April 2020

Online Academy

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, delegates 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.

Richard Young

Richard Young has over 20 years’ experience in the medical device industry, working with products from Class III implants to electromedical infusion systems. He has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited

  • Understand 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 manufacturing process
  • Comprehend business monitoring
  • Gather and analyse data using internal audits and corrective action processes
  • Gain an in-depth review of the Medical Device Single Audit Programme (MDSAP) and explore the country-specific aspects of it
  • Review audit guidance for MDSAP assessments
  • Cement your knowledge through MDSAP assessment case studies

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

 

MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.


Modules are released on a weekly basis so you can pace yourself alongside your peers and you will have access to a comprehensive set of assets to support your learning such as video content, quizzes and case studies.

 

Watch the Online Academy Video

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