Masterclass Certificate in Regulatory Compliance for Medical Printing

Name: Masterclass Certificate in Regulatory Compliance for Medical Printing
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The Masterclass Certificate in Regulatory Compliance for Medical Printing is a comprehensive course designed to meet the growing industry demand for experts with a deep understanding of medical printing regulations. This course equips learners with critical skills necessary for career advancement in this field.

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AboutThisCourse

By completing this course, learners will gain a solid foundation in the complex regulatory landscape of medical printing, including FDA regulations, ISO standards, and European Union Medical Device Regulations. They will also develop essential skills in risk management, quality control, and document management. With the medical printing industry projected to grow at a significant rate in the coming years, there is a high demand for professionals who can ensure regulatory compliance. This course provides learners with a valuable credential that can help them stand out in a competitive job market and advance their careers in this exciting field.

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CourseDetails

• Regulatory Framework for Medical Printing: Understanding FDA regulations, EU medical device directives, and other international standards for medical printing
• Medical Device Classification: Classifying medical devices and understanding the impact on regulatory requirements
• Design Controls for Medical Printing: Implementing design controls, including design inputs, outputs, and verification/validation activities
• Risk Management in Medical Printing: Applying ISO 14971 and other risk management standards to medical printing
• Labeling and Packaging Requirements: Meeting UDI, Unique Device Identification, and other labeling and packaging requirements
• Quality Management System for Medical Printing: Implementing a QMS, including document control, corrective and preventive action, and supplier management
• Clinical Evaluation and Testing: Conducting clinical evaluations and testing to demonstrate safety and effectiveness
• Post-Market Surveillance and Vigilance: Implementing post-market surveillance and vigilance programs to monitor and report adverse events
• Regulatory Submissions for Medical Printing: Preparing and submitting regulatory applications, including 510(k) premarket notifications, PMA premarket approvals, and EU Technical Files

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EntryRequirements

BasicUnderstandingSubject
ProficiencyEnglish
ComputerInternetAccess
BasicComputerSkills
DedicationCompleteCourse

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NotAccreditedRecognized
NotRegulatedAuthorized
ComplementaryFormalQualifications

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FastTrack GBP £140

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AcceleratedLearningPath

ThreeFourHoursPerWeek
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StandardMode GBP £90

CompleteInTwoMonths

FlexibleLearningPace

TwoThreeHoursPerWeek
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MASTERCLASS CERTIFICATE IN REGULATORY COMPLIANCE FOR MEDICAL PRINTING

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London College of Foreign Trade (LCFT)

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05 May 2025

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