E-Learning Of Regulatory Affairs Of Medical Device

Embrace regulatory joy of medical device

What you'll learn

Learn how to register medical device in international markets

Optimise the compilation of technical documentation

Manange of regulatory affairs skills

Know regulatory intelligence of medical device

Requirements

basic knowledge of medical device

eager to have intercultural communication

Description

We want to share regulatory intelligence with you indepedent in which career level you are staying at medtech. You will learn registration pathway from EU, MDR to US, FDA and CN NMPA etc…Learning audienceStudent and unemployed:Basic knowledge for Chinese registrationNon Medtech personal:Gain overview and tactic of Chinese market entry, useful for publication (medical writers)Non Regulatory personal:Perfect for career changerRegulatory professionals:Either with or without experience of  registration, improve registration efficiency, ideal as boot camp for RA groupOn website of easychinapprov, you can select any session what you wish to learnSession: Chinese accessSession: Registration in ChinaSession: Chinese Post market and quality managementSession: Global marketsSession: Regulatory Affairs Soft SkillsSession: FDA and CanadaSession: CE cerfiticationSession: Singapore, Malaysia and VietnamSession: TaiwanEach session is made of script, video, test and case study. In professional modul you can have face to face coach with our best chosen regulatory expert.Start: Participation possible any time.Duration: 1 yearHow to start: Kick off meeting with trainer, book trainingEnd of E-Learning: for professional user there is test, free supervision hours and certificateProof of E-learningA certificate will be issued after successful test for each session and qualitative homework.

Overview

Section 1: Overview of international registration of medical device

Lecture 1 From MDR to Chinese market of medical device

Lecture 2 From FDA to Chinese market of medical device

Section 2: Workflow of Chinese registration

Lecture 3 Pathway of Chinese registration

Lecture 4 Type testing

Section 3: Our Service

Lecture 5 E-Learning of regulatory affairs

Student,Junior regulatory affairs manager,Career changer in medtech