Professional Certificate in Regulatory Affairs for IVD Compliance
-- ViewingNowThe Professional Certificate in Regulatory Affairs for IVD Compliance is a crucial course for professionals seeking to navigate the complex world of in vitro diagnostic (IVD) regulation. This program focuses on the importance of regulatory compliance in the IVD industry, addressing the latest FDA and EU regulations.
4,063+
Students enrolled
GBP £ 149
GBP £ 215
Save 44% with our special offer
ๅ ณไบ่ฟ้จ่ฏพ็จ
100%ๅจ็บฟ
้ๆถ้ๅฐๅญฆไน
ๅฏๅไบซ็่ฏไนฆ
ๆทปๅ ๅฐๆจ็LinkedInไธชไบบ่ตๆ
2ไธชๆๅฎๆ
ๆฏๅจ2-3ๅฐๆถ
้ๆถๅผๅง
ๆ ็ญๅพ ๆ
่ฏพ็จ่ฏฆๆ
โข Regulatory Foundations for IVD Compliance: Understanding the legal and regulatory framework governing In Vitro Diagnostic (IVD) devices, including global regulations, guidelines, and standards.
โข Quality Management Systems (QMS) for IVDs: Establishing and maintaining a robust QMS in compliance with ISO 13485 and other relevant standards, focusing on design control, document control, and corrective and preventive action (CAPA).
โข IVD Classification and Risk Management: Identifying and classifying IVD devices based on risk levels and implementing risk management strategies to minimize potential harm to patients and users, in alignment with ISO 14971.
โข Labeling, Instructions for Use (IFU), and Promotion: Designing and implementing compliant labeling, IFU, and promotional materials, adhering to regional and global regulations, such as EU MDR, FDA, and IVDR.
โข Clinical Evidence and Performance Evaluation: Developing and executing clinical evidence strategies, performance evaluation plans, and post-market clinical follow-up studies to demonstrate the safety, performance, and effectiveness of IVD devices.
โข Post-Market Surveillance and Vigilance: Implementing and managing post-market surveillance and vigilance programs, ensuring timely reporting of adverse events and field corrective actions to regulatory authorities, in accordance with MEDDEV 2.12-1 rev. 8 and ISO 13485.
โข Regulatory Submissions and Approvals: Preparing and submitting technical documentation, applications, and notifications to regulatory agencies, such as FDA 510(k) premarket notifications, EU MDR/IVDR technical files, and Australian TGA submissions.
โข Supply Chain Management and Distribution: Managing suppliers, contract manufacturers, and distribution channels in compliance with regulatory requirements, including UDI (Unique Device Identification) regulations.
โข
่ไธ้่ทฏ
ๅ ฅๅญฆ่ฆๆฑ
- ๅฏนไธป้ข็ๅบๆฌ็่งฃ
- ่ฑ่ฏญ่ฏญ่จ่ฝๅ
- ่ฎก็ฎๆบๅไบ่็ฝ่ฎฟ้ฎ
- ๅบๆฌ่ฎก็ฎๆบๆ่ฝ
- ๅฎๆ่ฏพ็จ็ๅฅ็ฎ็ฒพ็ฅ
ๆ ้ไบๅ ็ๆญฃๅผ่ตๆ ผใ่ฏพ็จ่ฎพ่ฎกๆณจ้ๅฏ่ฎฟ้ฎๆงใ
่ฏพ็จ็ถๆ
ๆฌ่ฏพ็จไธบ่ไธๅๅฑๆไพๅฎ็จ็็ฅ่ฏๅๆ่ฝใๅฎๆฏ๏ผ
- ๆช็ป่ฎคๅฏๆบๆ่ฎค่ฏ
- ๆช็ปๆๆๆบๆ็็ฎก
- ๅฏนๆญฃๅผ่ตๆ ผ็่กฅๅ
ๆๅๅฎๆ่ฏพ็จๅ๏ผๆจๅฐ่ทๅพ็ปไธ่ฏไนฆใ
ไธบไปไนไบบไปฌ้ๆฉๆไปฌไฝไธบ่ไธๅๅฑ
ๆญฃๅจๅ ่ฝฝ่ฏ่ฎบ...
ๅธธ่ง้ฎ้ข
่ฏพ็จ่ดน็จ
- ๆฏๅจ3-4ๅฐๆถ
- ๆๅ่ฏไนฆไบคไป
- ๅผๆพๆณจๅ - ้ๆถๅผๅง
- ๆฏๅจ2-3ๅฐๆถ
- ๅธธ่ง่ฏไนฆไบคไป
- ๅผๆพๆณจๅ - ้ๆถๅผๅง
- ๅฎๆด่ฏพ็จ่ฎฟ้ฎ
- ๆฐๅญ่ฏไนฆ
- ่ฏพ็จๆๆ
่ทๅ่ฏพ็จไฟกๆฏ
่ทๅพ่ไธ่ฏไนฆ
