top of page
Online Meeting

Professional Training

Qualisure Consulting offers comprehensive online training programs designed for medical device professionals seeking to enhance their knowledge in quality management systems, risk management, regulatory compliance, and emerging technologies. All courses are delivered through interactive evening sessions with practical homework assignments and professional development certificates.

​

TRAINING DELIVERY MODEL
Format and Structure
​

  • Accessible Online evening sessions 

  • 2-hour interactive modules per session

  • Professional development workshops with certificates of attendance

  • Individual pay-to-attend enrollment

  • Knowledge-based learning with evidence of understanding

​​

Learning Methodology
​

  • Interactive presentations and discussions

  • Individual task completion for assessment

  • Homework assignments with feedback

  • Knowledge check quizzes at module completion

  • Final comprehensive assessment

  • Certificate upon successful completion

Available Courses

ISO 13485:2016 Medical Device Quality Management Systems

  • Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours

​

  • Target Audience: Quality managers, regulatory professionals, medical device manufacturers

​​

  • Certificate: Professional Development Certificate of Completion

ISO 13485 Clause-by-Clause Update

  • Duration: 2 modules × 2 hours + 4 hours homework = 8 total hours

​​

  • Target Audience: Professionals familiar with ISO 13485 seeking updates and detailed implementation guidance

​​

  • Certificate: Professional Development Certificate of Completion

ISO 14971:2019 Risk Management for Medical Devices

  • Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours

​​

  • Target Audience: Quality engineers, regulatory affairs professionals, design teams

​​

  • Certificate: Professional Development Certificate of Completion

Using AI in Medical Device Regulatory Affairs

  • Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours

​​

  • Target Audience: Regulatory and quality professionals implementing AI tools

​​

  • Certificate: Professional Development Certificate of Completion

EU MDR Medical Device Regulation

  • Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours

​​

  • Target Audience: Regulatory affairs professionals, quality managers, manufacturers

​​

  • Certificate: Professional Development Certificate of Completion

FDA Medical Device Regulations

  • Duration: 4 modules × 2 hours + 4 hours homework = 12 total hours

​​

  • Target Audience: Regulatory affairs professionals, quality managers, US market entrants

​​

  • Certificate: Professional Development Certificate of Completion

bottom of page