Professional Certificate in Implant Manufacturing: Regulatory Compliance
-- ViewingNowThe Professional Certificate in Implant Manufacturing: Regulatory Compliance is a crucial course for professionals seeking expertise in the highly regulated field of medical implant manufacturing. This certificate program, offered through flexible online learning, covers essential regulations and standards, ensuring compliance with FDA, ISO, and EU MDR requirements.
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⢠Regulatory Overview in Implant Manufacturing
⢠Understanding FDA Regulations for Implantable Devices
⢠Quality System (QS) Regulation and ISO 13485 Certification
⢠Design Control and Risk Management in Implant Manufacturing
⢠Document Control and Record Keeping
⢠Complaint Handling and MDR Reporting
⢠Sterilization Validation and Control
⢠Supplier Management and Control
⢠Internal and External Audits for Regulatory Compliance
⢠Ensuring Compliance in Implant Manufacturing: Best Practices
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