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United StatesPost Market Surveillance (PMS) Requirements Training
Post Market Surveillance (PMS) Requirements under the EU Medical Device Regulation (MDR) Training is for those looking to understand the PMS requirements under the EU MDR 2017/745 at their own pace, on their own schedule.
This interactive eLearning course is designed to equip quality and regulatory professionals, medical device manufacturers, and post-market teams with the knowledge to understand these rigorous requirements. This course covers every essential aspect of PMS under EU MDR.
What makes Comply Guru’s eLearning different from competitors is we instructionally design modules based on engaging, applied learning with real-world examples and case studies. Our online training is a highly interactive way to learn at a time & pace that works best for you, making it easier to get the training you need while balancing a busy home or work life.
This course is an internationally accredited credential. This training course recognized by the Regulatory Affairs Professionals Society (RAPS) offering global recognition for successful learners. RAPS members will also be eligible to receive 6 credits by completing this course.
Overview of our Post Market Surveillance (PMS) Requirements Training
What's covered on our PMS Requirements Training
An interactive, engaging eLearning experience that you can complete Anytime, Anywhere.
- What is PMS? – Definition and Purpose
- PMS and Device Classification
- PMS Link to Device Lifecycle
- Importance of PMS in Ensuring Safety and Performance
- Key Articles Related to PMS (Articles 83-86)
- PMS Requirements by Device Classification
- Relationship with ISO 13485 and ISO 14971
Case Study Analyze a scenario where a device’s PMS obligation were not met and the resulting consequences.
- Key Components of a PMS Plan (Article 84)
- Objectives and Strategy
- Data Sources for PMS Activities
- Responsibilities and Resources
- Practical Steps to Create a PMS Plan
Case Study Review of a PMS Plan
- Data Collection and Analysis
- Signal Detection and Trending
- Integration with Vigilance Activities
Case Study Identifying gaps in PMS Data Collection
- Periodic Safety Update Report (PSUR)
- PMS Report
- Integration with Technical Documentation
Case Study Identify the correct reporting requirements for different device classes
Michelle Keane
Eoin Philip Kelly
On completion of this course, successful Learners will have the knowledge to:
- Understand the core PMS requirements under EU MDR 2017/745
- Implement a risk-based PMS system aligned with QMS requirements
- Conduct PMS documentation effectively
- Comply with PSUR and PMS reporting obligations
- Integrate PMS into the regulatory and quality management strategy
- Quality Professionals
- Quality Engineers
- Regulatory Professionals
- Internal Auditors
- Lead Auditors
- Management Representatives
- Top Management
Before completing this course, each Learner should have the following prior knowledge:
EU MDR 2017/745
- Familiarity with the structure and key provisions of the EU Medical Device Regulation 2017/745.
- Basic knowledge of medical device classification and conformity assessment procedures under EU MDR.
ISO 13485
- Must have experience of working with ISO 13485:2016 or knowledge of ISO 13485:2016
Medical device management systems
Knowledge of the following quality management principles and concepts:
- The relationship between ISO 13485 and applicable international regulatory requirements for medical devices.
- The process approach used in quality management.
ISO 14971
- Basic understanding of ISO 14971
The Regulatory Affairs Professionals Society has approved Comply Guru (No. 1007) and recognizes this course where members will be eligible for the stated number of RAPS credits (6).
Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessment (MCQ-based)
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
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Frequently Asked Questions
Each license is for 12 months. Upon completion, the module content is still accessible for the full duration. However, the assessments cannot be re-completed once successfully passed (or if you exceed 3 attempts).
Each Learner has a maximum of 3 attempts at each assessment. We strongly encourage all learners to review & revise the course content again before each attempt (if unsuccessful on an attempt).
If unsuccessful after a 3rd attempt, you will not be eligible for certification. No refunds are possible due to a failed examination result.
If you register on the website, you will be able to access the eLearning within 1 hour of registering, subject to successful payment. If you are registering via Purchase Order, access will be enabled within 1 business day of payment being received.
Yes, we offer discounts for 5 or more learners on a scale based on the total number at the time of purchase. If you want to enquire about discounts, request a quote using the form on this page and a member of our team will be in touch.
Once you have successfully completed the training, including all assessments, your certificate will be available within 1 business day. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print from your learner dashboard.
Please note: no certificates are available without full payment on file.
Yes, we permit substitutions provided the license has not been activated and the request is made within 30-days of the purchase date. There is no fee for substitutions.
The eLearning duration provided is based on the average amount of time it takes an average learner who is new to the subject/topic, and has been independently verified by a globally recognized professional body, i.e. CQI and IRCA, RAPS, or Exemplar Global.
In reality, the amount of time it takes to complete the eLearning will vary depending on your prior experience, knowledge & learning style.
Extensions to the eLearning deadline (or license) are reviewed on a case by case basis. If you require an extension, please contact our team outlining your reason for the extension in advance of the expiration. Expired licenses cannot be reactivated or extended.
To complete this course successfully, you will need to fully complete each module and obtain 70% or higher in the applicable assessment(s).
All graded assessments are MCQ-based.
Not all eLearning is the same
Training Transformed with Comply Guru
What Our Learners Are Saying
4.5
Average Rating
6 global ratings
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Course most relevant to those with no or little prior PMS experience.
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Very suitable as an introduction to PMS and requirements for those without or limited prior knowledge. Really enjoyed the case studies
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This training was excellently executed. The content for an introductory course was sufficient and covered all key topics. The interactive knowledge based questions and case studies were great for embedding key points. Overall, a great training experience.
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I thought the PMS course was great and clear and concise content. From other courses i have done with comply guru I can definitely see there has been an effort to make the knowledge questions a bit harder where some of them you have to think which i think is excellent as it will indicate learnings.
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This is a great course for anyone trying to get up to speed with the PMS requirements of the EU Medical Device Regulation. It tackles the relevant sections of the regulation and breaks down their application according to device classification.
