Certified Professional in Regulatory Compliance for Medical Devices
-- viewing nowCertified Professional in Regulatory Compliance for Medical Devices (CPRCMD) equips professionals with essential knowledge for navigating the complex medical device regulatory landscape. This certification targets quality assurance, regulatory affairs, and compliance professionals in the medical device industry.
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Course details
• Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR)
• Risk Management (ISO 14971)
• Regulatory Affairs and Submissions
• Post-Market Surveillance and Vigilance
• Clinical Evaluation
• Cybersecurity in Medical Devices
• Good Manufacturing Practices (GMP) for Medical Devices
• Labeling and Packaging Requirements
Career path
Career Role (Medical Device Regulatory Compliance) | Description |
---|---|
Regulatory Affairs Specialist - Medical Devices | Ensures compliance with UK and EU medical device regulations (MDR, IVDR). Manages product registrations and licensing. |
Quality Assurance Manager - Medical Devices | Oversees quality systems, ensuring compliance with ISO 13485 and other relevant standards. Leads internal audits and CAPA processes. |
Compliance Officer - Medical Devices | Monitors regulatory changes, implements compliance programs, and conducts training. Acts as a central point of contact for regulatory matters. |
Senior Regulatory Affairs Manager - Medical Devices | Leads strategic regulatory planning, manages a team of regulatory affairs specialists, and interacts with regulatory agencies (MHRA). |
Entry requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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