Certified Professional in Medical Device Packaging Compliance
-- viewing nowCertified Professional in Medical Device Packaging Compliance (CPMDP) is designed for professionals needing expertise in medical device packaging regulations. This certification covers ISO 11607, EU MDR, and FDA regulations.
4,832+
Students enrolled
GBP £ 140
GBP £ 202
Save 44% with our special offer
About this course
100% online
Learn from anywhere
Shareable certificate
Add to your LinkedIn profile
2 months to complete
at 2-3 hours a week
Start anytime
No waiting period
Course details
• ISO 11607-2: Packaging materials for terminally sterilized medical devices
• ASTM F1980: Standard Guide for Packaging, Labeling, and Sterilization of Medical Devices
• USP <71>: Sterility tests
• ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
• 21 CFR Part 820: Quality System Regulation
• ISPE Good Practices Guide: Sterile Product Packaging
• EU Medical Device Regulation (MDR) 2017/745
• FDA Guidance Documents on Medical Device Packaging
Career path
Job Title (Certified Professional in Medical Device Packaging Compliance) | Description |
---|---|
Packaging Engineer (Medical Devices) | Develops and validates packaging solutions for medical devices, ensuring compliance with regulations like ISO 11607. Focuses on material selection, design, and testing. |
Regulatory Affairs Specialist (Medical Device Packaging) | Manages regulatory submissions and ensures compliance with all relevant guidelines concerning medical device packaging. A key role in maintaining compliance. |
Quality Assurance Auditor (Medical Device Packaging) | Audits packaging processes and documentation to ensure adherence to quality standards and regulatory requirements. Crucial for maintaining product quality and safety. |
Packaging Validation Specialist (Medical Devices) | Specializes in validating packaging processes and ensuring sterility, integrity, and protection of medical devices throughout their shelf life. |
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.
Why people choose us for their career
Loading reviews...
Frequently Asked Questions
Course fee
- 3-4 hours per week
- Early certificate delivery
- Open enrollment - start anytime
- 2-3 hours per week
- Regular certificate delivery
- Open enrollment - start anytime
- Full course access
- Digital certificate
- Course materials
Get course information
Earn a career certificate
