Course Name
Medical Device Regulation (EU) 2012: MDR 2017/745 Compliance Training
Course Overview
Welcome to the Medical Device Regulation (EU) 2012: MDR 2017/745 Compliance Training provided by ARG Academy. This comprehensive program is designed to help organizations navigate the European Union’s regulatory landscape and understand the key differences between the previous Medical Device Directive (MDD) and the current MDR. The curriculum is structured systematically, with Day 1 focusing on the regulatory framework, economic operators, and QMS, followed by Day 2 which serves as a masterclass on risk classification, technical documentation, and clinical evaluation.
Course Objective
By the end of this MDR 2017/745 Compliance Training, participants will be fully equipped to:
● Master MDR 2017/745: Navigate the EU regulatory framework and device safety objectives.
● Determine Classifications: Map conformity assessment routes for Class I, IIa, IIb, and III devices.
● Achieve CE Marking: Compile fully compliant technical documentation.
● Manage Clinical Evidence: Execute robust PMS and PMCF surveillance systems.
● Define Operator Roles: Clarify compliance duties for manufacturers, importers, and distributors.
● Align QMS & Risk: Integrate ISO 14971 and ISO 13485 directly with MDR requirements.
● Ace Regulatory Audits: Prepare for Notified Body interactions and strict UDI traceability.
Course Benefits
Participating in this MDR 2017/745 Compliance Training provides critical advantages for both professionals and their organizations:
● Trainees will become capable of contributing effectively to their organization’s overall compliance strategy for MDR 2017/745.
● The training ensures the successful launch and ongoing maintenance of medical devices within the EU Market.
● Participants will learn the exact steps required to transition existing devices and processes to comply fully with the new MDR standards.
Who Must Attend
Based on the course objectives, this training is essential for:
● Key economic operators targeting the EU market, including manufacturers, authorized representatives, importers, and distributors.
● Quality and regulatory professionals responsible for establishing QMS aligned with ISO 13485, technical documentation, and CE marking.
● Personnel involved in risk management (ISO 14971), clinical evaluation, performance studies, and post-market surveillance.
● Staff tasked with managing regulatory audits, inspections, vigilance reporting, and interactions with Notified Bodies.
Methodology
The MDR 2017/745 Compliance Training course utilizes an interactive lesson plan designed to facilitate practical understanding:
● Facilitator-Led Instruction: Trainers will illustrate overviews of complex topics (like the regulatory framework, clinical evaluation, and risk classification) using PowerPoint presentations, flip charts, and handouts.
● Active Engagement: The program starts with a 30-minute ice-breaker asking participants to elaborate on the question, “What is Medical Device Regulation (EU) 2012-2017/745?”.
● Participant Practice: Attendees will actively participate by writing down what they know about the regulatory framework, answering provided questionnaires, and engaging in Q&A sessions.
● Structured Wrap-Up: The course concludes with a 5-minute summary review of the entire presentation and a 2-minute knowledge transfer session to distribute MDR training materials and ISO/EN guidelines.
Course Duration
● The core curriculum of this training is delivered over Day 1 and Day 2.
● The daily schedule incorporates specific time allocations for structured learning, including a 30-minute introduction, a 5-minute summary review, and 2 minutes for transferring reference guidelines.
HRD Corp Claimable Course
This is a 100% HRD Corp Claimable Training
Stop letting your monthly levy sit idle. Upgrade your workforce with our fully approved corporate training programs under the HRD Corp Claimable Course.
Why Choose ARG Academy?
● No Out-of-Pocket Cash: Fees are deducted directly from your e-TRiS account.
● Certified Trainers: All programs are led by HRD Corp TTT-approved experts.
● Zero Paperwork Hassle: We assist you with the entire grant application process.
● Flexible Programs: Tailored courses in Leadership, Digital Skills, Sales, and Soft Skills.
Secure Your Training Grant Today
Don’t let your training budget go to waste this year while regulatory requirements continue to tighten. Equip your team with the skills they need to ensure total medical device compliance. Book your corporate MDR 2017/745 Compliance Training slot today and empower your QA team. Click the Enquiry button below to reserve your seats now.
