Masterclass Certificate in Medical Device Regulation
-- viewing nowMedical Device Regulation Masterclass: Gain the expertise needed to navigate the complex world of medical device compliance. This certificate program is designed for regulatory affairs professionals, quality assurance managers, and medical device engineers seeking to enhance their knowledge of FDA regulations, EU MDR, and ISO 13485.
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Course details
• EU Medical Device Regulation (MDR) 2017/745 & In Vitro Diagnostic Regulation (IVDR) 2017/746
• US Food and Drug Administration (FDA) Regulations for Medical Devices
• Quality Management Systems (QMS) - ISO 13485:2016
• Risk Management & Clinical Evaluation
• Regulatory Strategy & Pathway Selection
• Post-Market Surveillance & Vigilance
• Medical Device Labeling and Packaging Requirements
• Cybersecurity in Medical Devices
• Global Harmonization of Medical Device Regulations
Career path
Masterclass Certificate in Medical Device Regulation: UK Career Outlook
Career Role | Description |
---|---|
Regulatory Affairs Specialist (Medical Devices) | Ensure compliance with UK and EU medical device regulations. A crucial role in product lifecycle management. |
Quality Assurance Manager (Medical Devices) | Oversee quality systems and compliance for medical device manufacturing and distribution. High demand for quality professionals. |
Clinical Affairs Specialist (Medical Devices) | Manage clinical trials and post-market surveillance, ensuring patient safety and regulatory compliance. Strong clinical knowledge is vital. |
Medical Device Consultant | Provide expert guidance on regulatory strategies and compliance to medical device companies. Requires extensive experience and expertise. |
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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