Professional Certificate in MedTech Compliance for Regulatory Specialists
-- ViewingNowThe Professional Certificate in MedTech Compliance for Regulatory Specialists is a comprehensive course designed to meet the growing industry demand for experts who can navigate the complex regulatory landscape of the medical technology sector. This certificate program equips learners with essential skills in regulatory affairs, quality management, and compliance strategies, making them highly valuable to organizations in need of specialists who can ensure adherence to evolving industry standards and guidelines.
3,788+
Students enrolled
GBP £ 140
GBP £ 202
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 in MedTech: Understanding the legal and regulatory landscape of the medical technology industry, including key agencies and regulations such as FDA, MDR, and IVDR.
โข Quality Management Systems (QMS): Establishing and maintaining a QMS for MedTech companies, including ISO 13485 and FDA Quality System (QS) regulation.
โข Clinical Evaluation and Investigations: Designing, conducting, and reporting clinical evaluations and investigations to demonstrate safety and performance of MedTech products.
โข Risk Management in MedTech: Implementing risk management processes in accordance with ISO 14971 and FDA requirements.
โข Labeling and Promotion Compliance: Ensuring compliant labeling and promotion of MedTech products, including off-label use and advertising restrictions.
โข Post-Market Surveillance and Vigilance: Monitoring and reporting adverse events and implementing corrective and preventive actions.
โข Regulatory Submissions and Approvals: Preparing and submitting regulatory applications for MedTech products, including 510(k), PMA, De Novo, and CE Marking.
โข Regulatory Audits and Inspections: Preparing for and managing regulatory audits and inspections, including responding to 483s and warning letters.
โข Global MedTech Regulatory Trends: Staying up-to-date with emerging global trends and regulatory changes impacting the MedTech industry.
่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
