Online & Self-Paced Comprehensive EU In-Vitro Diagnostic Regulation (EU-IVDR 2017/746) Practitioner Course
★★★★★
Overview
Comply Guru™ are proud to be partnering with Meddev Solutions in bringing to market this Exemplar Global certified Comprehensive EU In-Vitro Diagnostic Regulation (EU-IVDR 2017/746) Practitioner Course – it will be the first and most comprehensive online & self-paced course to be released in the world!
Meddev Solutions are a team of QARA professionals, each with a minimum of 20 years’ experience, working in the medical device industry for both manufacturers and Notified Bodies.
Our course provides an in-depth foundation on the key principles and practices required for the new European In-Vitro Diagnostic Regulation (IVDR) 2017/746.
There are 7 course objectives:
- Explain the history, purpose and structure of the EU IVDR, and the key terminology used throughout the regulation
- Identify the types of device covered by the EU IVDR, the rules for classification and the routes to conformity
- Describe the obligations of the economic operators and the PRRC
- Describe the General Safety & Performance Requirements
- Outline the requirements for Performance evaluation and Performance studies
- Explain the Post Market Surveillance and Vigilance reporting requirements
- Describe the contents of the Technical Documentation and explain the Unique Device Identifier requirements
Course Snapshot
Course Duration:
18 HoursContinuing Education Units:
1.8Format
Online & Self-Paced CourseAccreditation
Delivery Options & Discounts
- Discounts Available for 5+ Licenses. Request a Quote!
Price
1,375 (Pre-Order Rate Only)Fee Includes
- Course Access for 90 days
- Virtual Instructor Assistance – Phone & Email Support



Finally, an industry-leading online & blended training solution for ISO Standards, Quality Auditing & Medical Device Training!
Comply Guru LLC, based in Chicago, IL, offers a growing portfolio online & blended training courses on various ISO Standards, Quality Auditing and Medical Device Regulations to enable its Learners to get the knowledge and skills they need from home, work or anywhere!
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The Numbers - How We Are Doing
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Our Pass Rate
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Would Recommend Comply Guru
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Gave us 4/5 Stars or higher Overall Training Experience
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Would Recommend Online or Blended Training over Classroom Training