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First Course

Nebojsa Serafimovic
Nebojsa Serafimovic
Course Hours 16-17.06.23
Lessons 1 Session
$100 Per person

Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

Course Time 29 Min
Lessons 1 Lesson
$80 Per person

Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies

Course Time 34 Min
Lessons 1 Lesson
$80 Per person

Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR

Course Time 22 Min
Lessons 1 Lesson
$70 Per person

Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements

Course Time 46 Min
Lessons 1 Lesson
$75 Per person

General Data Protection Regulations in the EU

Course Time 27 Min
Lessons 1 Lesson
$80 Per person

Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance

Course Time 29 Min
Lessons 1 Lesson
$75 Per person

MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them

Course Time 45 Min
Lessons 1 Lesson
$70 Per person

Standards, Harmonisation Process and Common Specifications

Course Time 29 Min
Lessons 1 Lesson
$75 Per person

General Safety and Performance Requirements under the Medical Devices

Course Time 29 Min
Lessons 1 Lesson
$75 Per person

Software, Artificial Intelligence and Cybersecurity in the European Union

Course Time 27 Min
Lessons 1 Lesson
$75 Per person

Issues Arising from the Implementation of the IVD-Regulations

Course Time 28 Min
Lessons 1 Lesson
$80 Per person

Clinical Evaluation, Investigations and PMCF under MDR

Course Time 33 Min
Lessons 1 Lesson
$75 Per person

Major Regulatory Compliance Challenges for the Non-European Industry

Course Time 29 Min
Lessons 1 Lesson
$75 Per person

Benefit Risk Assessment

Course Time 18 Min
Lessons 1 Lesson
$75 Per person

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Our Channels

Biowise delivers you updated online courses in most of the bio fields: Medical devices, pharma, cosmetics, clinical trials, cannabis, Diagnostics and more

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Medical Devices

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Clinical Trials

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Pharma

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Diagnostics

Our Lecturers

Access courses 24/7 & learn from our experts in the industry

biowise specializes in providing comprehensive information and updates in all areas of Bio-medical, through courses and lectures on demand. 

Our Mission

Our Vision

Our vision is to help disseminate cutting-edge knowledge for the international biotech and biomed community by providing a superior platform from which Key Opinion Leaders are able to guide the decision-makers through the myriad of information.

biowise is at the frontline of Sharing Medical Knowledge through informative, sharp, high quality courses.

Our Values

Biowise values your time and opinion which is why we initiated Biowise to facilitate the evaluation of new ideas and new research in a creative, engaging setting which promotes active dialogue between industry and professionals from the biomedical arena.