Be an expert in Risk Management (ISO 14971) and QMS (ISO 13485) activities and create PFMEA, DFMEA, CEA, PHA like a pro!

What you’ll learn

  • Become an expert in creating Risk Management documents from scratch, such as PFMEA, DFMEA, FTA, PHA etc for Medical device and Pharmaceutical companies.
  • In-depth understanding of Regulatory standards such as ISO 14791:2019, EU 2017/745 MDR, 21 CFR 820, SOR/98-282 and ISO13485.
  • Be proficient in what Food and Drug Administration (FDA) auditors are looking for while doing Quality audits for Risk Management activities
  • Learn why CAPA, Non conformances, IQ/OQ/PQ, complaint handling process are crucial for medical device industry
  • Learn in-depth about Quality Management system (QMS) regulations from different countries around the world


  • No prerequisite required. Course progresses from basic to advanced level with easy to grasp content and real world examples.


  • This course is designed to teach you everything that you need to know to become a Subject Matter Expert (SME) in Risk Management  and Quality Management System (QMS) within Medical device and Pharmaceutical industry.

  • Regardless of your current skills and experience, after taking this course, you will be comfortable communicating to experts in medical device industry about Quality management systems (QMS) and risk management (RM) standards and regulations.

  • You will learn how to draft complex RM documents such as PFMEA, DFMEA, Benefit-Risk Analysis, Post Market Surveillance Report (PMSR), Clinical Effects Analysis Report (CEA) from the scratch! Knowing this skills will set you apart from the crowd and you can easily land you six-figure jobs in a reputed medical device companies.

  • You will be well versed in rules, regulations and standards for medical device industries across the world such as ISO 14971 (Risk Management, ISO) , 21 CFR 810 (FDA, USA), RDC 40/2015 (Anvisa, Brazil), EU 2017/745 MDR, MHLW MO 169 (PMDA, Japan) and TGR 2002 (TGA, Austrialia) and be able to talk about them in meetings, interviews and even with auditors.

  • You will learn how processes like complaint reviews, Corrective and Preventative Maintenance (CAPA), Process Validation (PV), Equipment Qualification (IQ/OQ/PQ) ties into Risk Management and why companies need to do these activities.

  • Whether you are just getting into Risk Management, or wants to freshen up your skills, or are looking to advance your career in the field, this course can provide you with more than enough knowledge to be the top 5% in your organization.

Who this course is for:

  • Professionals looking to be promoted or looking to get into medical device or pharmaceutical industry