Certified Specialist Programme in Biomedical Device Licensing
-- ViewingNowBiomedical Device Licensing: Master the complexities of navigating regulatory pathways. This Certified Specialist Programme is designed for regulatory affairs professionals, quality assurance specialists, and biomedical engineers involved in medical device development and commercialization.
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完了まで2ヶ月
週2-3時間
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待機期間なし
コース詳細
- Regulatory Pathways for Biomedical Devices
- Quality System Regulations (QSR) and ISO 13485
- Risk Management for Medical Devices
- Design Controls and Verification & Validation
- Clinical Evaluation and Post-Market Surveillance
- Labeling and Packaging Requirements
- Submission and Review Process of Regulatory Documents
- International Harmonization of Medical Device Regulations
- Good Manufacturing Practices (GMP) for Medical Devices
- Cybersecurity for Medical Devices
キャリアパス
Career Role Description Regulatory Affairs Specialist (Biomedical Devices) Oversee compliance with UK and EU regulations for biomedical device licensing, ensuring product safety and market access.
High demand for experience in Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) .
Clinical Engineer (Biomedical Devices) Bridge the gap between engineering and clinical practice, specializing in the installation, maintenance, and troubleshooting of biomedical devices in healthcare settings.
Strong understanding of biocompatibility and device safety is crucial.
Biomedical Device Compliance Manager Lead the compliance efforts for a company's biomedical device portfolio, ensuring conformity to all relevant standards and regulations.
Expertise in quality management systems (QMS) like ISO 13485 is essential.
Biomedical Device Technician Perform routine maintenance and repair of a wide variety of biomedical devices.
Requires practical experience and detailed knowledge of device functionality and troubleshooting techniques .
入学要件
- 主題の基本的な理解
- 英語の習熟度
- コンピューターとインターネットアクセス
- 基本的なコンピュータースキル
- コース完了への献身
事前の正式な資格は不要。アクセシビリティのために設計されたコース。
コース状況
このコースは、キャリア開発のための実用的な知識とスキルを提供します。それは：
- 認可された機関によって認定されていない
- 認可された機関によって規制されていない
- 正式な資格の補完
コースを正常に完了すると、修了証明書を受け取ります。
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