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Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications
Critical Considerations in Site Selection and Subject Enrollment in Device and IVD Clinical Studies
Competent Authority Expectations and Management of Device Clinical Study Applications Under the MDR
Developing Clinical Investigation and Performance Study Plans That Meet Regulatory and Operational Requirements
General Data Protection Regulations in the EU
Aligning Clinical Investigations and Risk Management to Ensure MDR Compliance
MDR Requirements for Sponsor GCP Inspections (audits) and How to Conduct Them
Standards, Harmonisation Process and Common Specifications
General Safety and Performance Requirements under the Medical Devices
Software, Artificial Intelligence and Cybersecurity in the European Union
Issues Arising from the Implementation of the IVD-Regulations
Clinical Evaluation, Investigations and PMCF under MDR
Major Regulatory Compliance Challenges for the Non-European Industry
Benefit Risk Assessment
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biowise specializes in providing comprehensive information and updates in all areas of Bio-medical, through courses and lectures on demand.
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.
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.