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.

You could even bring non-compliance from the field and would challenge yourself with case study.

Unique features of E-learning:

Free one to one supervisor with trainer
Test and case study with professional and personal feedback
Possible expert opinion for current registration and other strategy
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

Student and unemployed: Basic knowledge to find a job
Non Medtech personal: Gain overview and tactic of global market entry, useful for publication, M&A, marketing and sales
Non regulatory personal: Perfect for career changer and personal with interface with regulation
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.

4.0 Global registration

4.1 From MDR to NMPA (China)

4.2 Comparison between Chinese and US market

4.3 Registration strategy

4.4 Taiwan

4.5 Brazil

Session 2: Chinese access

In this session you will learn the basic knowledge of Chinese registration of medical device and IVD.

1.0 Roadmap of Chinese registration

1.1 Chinese authority: NMPA

1.2 Chinese agent

1.3 Chinese certificate

1.4 Type of registration

1.5 Classification and product code

1.6 Time and cost

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.

2.1 Type Testing

2.2 Product technical requirement

2.3 Technical documentation

2.4 Clinical study and clinical trial

2.5 Chinese labelling

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.

3.0 Post market surveillance

3.1 Chinese vigilance system

3.2 Significant change

3.3 Periodic Risk Evaluation Report

Session 5: US registration

FDA is the most modern and professional agency. All RA enthusiasts should learn it.

4.1 Legislative

4.2 Quality system

4.3 Type of registration

4.4 Classification and product code

4.4 510k

4.5 When to new registration

4.6 Post market activities (surveillance)

Session 6: European markets

5.1 What is MDR and other regulation in EU?

5.2 QM certification

5.3 CE certification

5.4 Technical documentation

5.5 Swiss

5.6 UK

Session 7: Regulatory Affairs Soft Skills

The soft skills of regulatory affairs is the key besides regulatory know how.

5.1 Regulatory affairs soft skills

5.2 Kaizen in regulatory business

Proof of Elearning

A certificate will be issued after successful test for each session and qualitative homework.

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.

Individual compliance module

From 400 EUR

At least 3 sessions
Videos
Multi choice Tests
90 Min free consulting with trainer

Professional compliance module

From 1200 EUR

At least 5 sessions
+ 40 topics
+ 20 videos
+ 10 Free template
Multi choice tests with case study
200 Min free consulting with trainer