Course Entry Criteria

Prior to attending this course learners are expected to have the following prior knowledge:

ISO 13485 Lead Auditor Training

• Must have recently completed a CQI & IRCA Certified ISO 13485:2016 Lead Auditor course or equivalent

Comprehensive EU-MDR 2017/745 Practitioner Training

• Knowledge of the EU MDR requirements related to economic operators, quality management system requirements, product classification, conformity assessment routes, clinical evaluation, technical documentation, product realization (including UDI), and postmarket surveillance, which may be gained by completing our CQI & IRCA Certified Comprehensive EU-MDR 2017/745 Practitioner course which is included with this course
• If any Learner has already completed Comply Guru’s Comprehensive EU-MDR Practitioner course, they will be granted both a credit & an exemption from completing this 20hr segment of the training

Management Systems Audit

• Knowledge of management systems audit through satisfactory completion of a CQI and IRCA Certified Lead Auditor Training course (or acceptable alternative).
• Important Note: Learners who have not satisfactorily completed a CQI and IRCA Certified Lead Auditor training course (or acceptable alternative) are unlikely to successfully complete this 40-hour course and will first need to complete a certified lead auditor course.

Medical Device Management Systems

Knowledge of the following quality management principles and concepts:
• • The Plan, Do, Check, Act (PDCA) cycle
  • The relationship between ISO 13485 and applicable international regulatory requirements for medical devices
  • Commonly used quality management terms and definitions within ISO 13485 and ISO 9000
  • The process approach used in quality management
  • A good working knowledge of the EU Medical Device Regulation and its relationship with ISO 13485
  • A working knowledge of risk management principles related to the design of a medical device, through ISO 14971.
  Important Note: The course examination may ask questions that relate to prior knowledge that will not be covered in this course.

E-Learning System Requirements

The below are the recommended requirements for each Learner in wishing to complete any of our online training courses or 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.

Recommended Operating Systems

Windows 7/10, Mac OSX Sierra, iPad IOS10

Mobile Devices

Comply Guru’s LMS is not available on a mobile app at this time. We recommend using a web browser on a mobile device in completing any online modules. However, if completing any final graded assessment, we recommend completing via a desktop browser.

Internet Speed

We recommend using an internet connection of 256Kbit/sec or faster that will ensure that you can view videos and the online content

Recommended Internet Browsers

• Google Chrome 32 bit version 50 or later
• Safari 10 or later

Important Note: add-ons and toolbars can affect any browsers performance. MS Internet Explorer or Edge are not recommended as its not compatible with the LMS and the course functionality will not work properly.

Recommended Settings

We recommend that the following settings are enabled:

• Cookies
• Pop-ups (in both Internet Browser and security software)
• JavaScript
• Plugins
• Latest Version of Adobe Flash Player
• Latest Version of Adobe Acrobat Reader

To view all resources made available within our LMS, you will probably need Microsoft Office (Word, Excel, PowerPoint) or an equivalent (i.e Open Office, Viewer) installed.

Technology Requirements for Virtual Training

To participate in the virtual training sessions, you will need:

• Laptop or desktop computer (Note: A tablet or mobile device is not suitable for this training)
• Webcam – Built-in or USB plug-in
• Speakers and a microphone – Built-in or USB plug-in. We strongly recommend a headset if you have this available
• Internet connection – Minimum of 1.0Mbps