Comprehensive Medical Device Training Programs
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