One year Mycompliance Academy
Welcome to our 1 year academy of Chinese and global Compliance of medical device. Other than many commercial machines E-Learnings we have from the beginning ONE trainer for EACH student. You can choose to learn product development, regulatory affairs, quality management, post market in interested critical markets.
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You could even bring non-compliance from the field and would challenge yourself with case study.
Unique features of E-learning:
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Free one to one supervisor with trainer
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Test and case study with professional and personal feedback
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Possible expert opinion for current registration and other strategy
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Update of new Chinese registration, videos and templates
Participation possible any time, 24 hours a day, 7 days a week, valid for 1 year.
Learning audience
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Student and unemployed: Basic knowledge to find a job
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Non Medtech personal: Gain overview and tactic of global market entry, useful for publication, M&A, marketing and sales
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Non regulatory personal: Perfect for career changer and personal with interface with regulation
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Regulatory professionals: either with or without experience, improve registration efficiency, ideal as boot camp for RA group
Leaning objective
Session 1: Global markets
We will gain some global impression how the registration of medical device and IVD in other markets look like.
1.0 Global registration
1.1 From MDR to NMPA (China)
1.2 Comparison between Chinese and US market
1.3 Registration strategy
1.4 Taiwan
1.5 Brazil
1.6 ASEAN, Singapore, Malaysia and Vietnam
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Session 2: Chinese access
In this session you will learn the basic knowledge of Chinese registration of medical device and IVD.
2.0 Roadmap of Chinese registration
2.1 Chinese authority: NMPA
2.2 Chinese agent
2.3 Chinese certificate
2.4 Type of registration
2.5 Classification and product code
2.6 Time and cost
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Session 3: Registration in China
In this session we will dig deeper to important steps prior to and during the Chinese registration of medical device and IVD.
3.1 Type Testing
3.2 Product technical requirement
3.3 Technical documentation
3.4 Clinical study and clinical trial
3.5 Chinese labelling
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Session 4: Chinese Post market and quality management
After product approval by authority you should know the post market and quality management activities in Chinese market.
4.0 Post market surveillance
4.1 Chinese vigilance system
4.2 Significant change
4.3 Periodic Risk Evaluation Report
4.4 Overseas inspection
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Session 5: US registration
FDA is the most modern and professional agency. All RA enthusiasts should learn it.
5.1 Legislative
5.2 Quality system
5.3 Type of registration
5.4 Classification and product code
5.4 510k
5.5 When to new registration
5.6 Post market activities (surveillance)
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Session 6: European markets
6.1 What is MDR and other regulation in EU?
6.2 QM certification
6.3 CE certification
6.4 Technical documentation
6.5 Swiss
6.6 UK
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Session 7: Regulatory Affairs Soft Skills
The soft skills of regulatory affairs is the key besides regulatory know how.
7.1 Regulatory affairs soft skills
7.2 Kaizen in regulatory business
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Proof of E-Learning
A certificate will be issued after successful test for each session and qualitative homework.
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Payment
It is payed at the beginning of E-learning, valid for 1 year.
Cancellation is possible in 14 days free and with refund of 20% course payment in 2 months. The cancellation is not valid if more than 2 sessions in professional compliance was completed or templated was sent to client already.
The student and unemployed has 30% discount according to evidence.
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Individual compliance module
From 400 EUR
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At least 3 sessions
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Videos
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Multi choice Tests
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90 Min free consulting with trainer
Professional compliance module
From 1200 EUR
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At least 5 sessions
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+ 40 topics
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+ 20 videos
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+ 10 Free template
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Multi choice tests with case study
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200 Min free consulting with trainer
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