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Essential Components of European Medical Device Regulations
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Highlights
On-Demand course
1 hour 48 minutes
All levels
Description
Unlock the secrets to navigating the intricate landscape of European medical device regulations with our comprehensive course. Designed for those who seek mastery in understanding and applying the latest EU standards, this course is your gateway to compliance excellence. Dive deep into the regulatory environment, where you'll explore the essential components that govern the medical device industry in Europe. Learn how to seamlessly integrate these regulations into your practice, ensuring your products meet the highest standards of safety and efficacy.
Key Features:
CPD Certified
Free Certificate from Reed
CIQ Approved
Developed by Specialist
Lifetime Access
Discover the nuances of reporting requirements and identification processes, critical for maintaining transparency and accountability. Our expertly curated content guides you through establishing a robust quality system, pivotal for regulatory success. Equip yourself with the knowledge to confidently manage regulatory submissions and navigate quality audits with ease. Join a community of like-minded professionals and elevate your regulatory expertise, ensuring your organisation stays ahead in the competitive medical device market. Enrol now to transform your approach to European medical device regulations and lead with confidence in a compliant and efficient manner.
Course Curriculum
Module 01: Overview to European Regulations on Medical Devices
Module 02: Essential Components of EU MDR
Module 03: Reporting Requirements and Identification
Module 04: Quality System in Medical Device Regulation
Learning Outcomes:
Understand the core elements of European medical device regulations.
Identify key components of EU Medical Device Regulation (MDR).
Master reporting requirements and device identification processes.
Implement quality systems in medical device regulation.
Analyse essential EU MDR regulatory requirements.
Navigate the complexities of EU medical device compliance.
CPD
10 CPD hours / points Accredited by CPD Quality Standards
Essential Components of European Medical Device Regulations 1:45:07 1: Module 01: Overview to European Regulations on Medical Devices 33:17 2: Module 02: Essential Components of EU MDR 29:12 3: Module 03: Reporting Requirements and Identification 16:21 4: Module 04: Quality System in Medical Device Regulation 25:17 5: CPD Certificate - Free 01:00
Who is this course for?
Regulatory affairs specialists in the medical device industry.
Quality assurance professionals in healthcare.
Compliance officers in medical device companies.
Medical device product managers.
Legal advisors in healthcare regulation.
Career path
Regulatory Affairs Specialist
Quality Assurance Manager
Compliance Officer
Medical Device Consultant
Product Manager
Regulatory Affairs Associate
Certificates
Digital certificate
Digital certificate - Included
Reed Courses Certificate of Completion
Digital certificate - Included
Will be downloadable when all lectures have been completed.
About The Provider
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