Global Certificate in Regulatory Strategies for Medical Devices

-- ViewingNow

The Global Certificate in Regulatory Strategies for Medical Devices is a comprehensive course that equips learners with critical skills in navigating the complex regulatory landscape of the medical device industry. This course emphasizes the importance of designing and implementing effective regulatory strategies to ensure compliance and market access for medical devices.

4.5
Based on 2,553 reviews

4,961+

Students enrolled

GBP £ 140

GBP £ 202

Save 44% with our special offer

Start Now

ๅ…ณไบŽ่ฟ™้—จ่ฏพ็จ‹

With the growing demand for medical devices and increasing regulatory requirements, this course provides learners with a competitive edge in their careers. It covers essential topics such as regulatory pathways, clinical trials, quality management systems, and post-market surveillance. Learners will also gain practical experience in developing and implementing regulatory strategies for medical devices. By completing this course, learners will be able to demonstrate their expertise in regulatory affairs, improve their marketability in the medical device industry, and advance their careers. This course is ideal for professionals working in regulatory affairs, quality assurance, and product development in medical device companies, as well as those looking to enter the industry.

100%ๅœจ็บฟ

้šๆ—ถ้šๅœฐๅญฆไน 

ๅฏๅˆ†ไบซ็š„่ฏไนฆ

ๆทปๅŠ ๅˆฐๆ‚จ็š„LinkedInไธชไบบ่ต„ๆ–™

2ไธชๆœˆๅฎŒๆˆ

ๆฏๅ‘จ2-3ๅฐๆ—ถ

้šๆ—ถๅผ€ๅง‹

ๆ— ็ญ‰ๅพ…ๆœŸ

่ฏพ็จ‹่ฏฆๆƒ…

โ€ข Global Regulatory Frameworks: Understanding the international regulatory landscape for medical devices, including FDA (USA), CE (Europe), MHLW (Japan), and SFDA (China).
โ€ข Regulatory Pathways: Overview of regulatory pathways for medical devices, including premarket approval (PMA), 510(k) clearance (USA), and Conformitรฉ Europรฉene (CE) marking (Europe).
โ€ข Quality System Regulations: Compliance with Quality System Regulations (QSR) and ISO 13485:2016, focusing on design controls, document controls, and corrective and preventive actions (CAPA).
โ€ข Clinical Evaluation and Investigations: Designing and conducting clinical evaluations and investigations according to regulatory requirements, including clinical evaluation reports (CERs) and investigational device exemptions (IDEs).
โ€ข Labeling and Packaging: Compliance with labeling and packaging regulations, including Unique Device Identification (UDI) and Instructions for Use (IFU).
โ€ข Post-Market Surveillance: Monitoring and reporting adverse events, implementing post-market surveillance studies, and complying with Medical Device Reporting (MDR) requirements and vigilance reporting.
โ€ข Regulatory Submissions: Preparing and submitting regulatory applications, including electronic submissions via eCopy and eCTD.

่Œไธš้“่ทฏ

In the UK, professionals with the Global Certificate in Regulatory Strategies for Medical Devices can explore various lucrative roles. Here are some prominent positions in the industry and their respective job market shares, visualized using a 3D pie chart. - **Regulatory Affairs Specialist** (45%): These professionals manage regulatory compliance and ensure that medical devices meet the necessary requirements. They typically collaborate with R&D teams, manage submissions, and update technical documentation. - **Clinical Affairs Specialist** (25%): Clinical affairs specialists focus on the clinical aspects of medical device development and commercialization. They play a crucial role in designing and conducting clinical studies, preparing clinical evaluation reports, and liaising with healthcare professionals. - **Quality Assurance Specialist** (15%): Quality assurance specialists ensure that medical devices are manufactured and tested according to the required standards. They establish quality management systems, monitor production processes, and conduct internal audits to maintain high-quality products. - **Medical Writer** (10%): Medical writers create clear, accurate, and engaging content related to medical devices. They may develop product labels, user manuals, promotional materials, and scientific articles, ensuring compliance with regulations and industry standards. - **Regulatory Affairs Manager** (5%): Regulatory affairs managers oversee teams responsible for regulatory compliance. They develop strategies to navigate complex regulatory landscapes, build relationships with regulatory authorities, and provide guidance to cross-functional teams.

ๅ…ฅๅญฆ่ฆๆฑ‚

  • ๅฏนไธป้ข˜็š„ๅŸบๆœฌ็†่งฃ
  • ่‹ฑ่ฏญ่ฏญ่จ€่ƒฝๅŠ›
  • ่ฎก็ฎ—ๆœบๅ’Œไบ’่”็ฝ‘่ฎฟ้—ฎ
  • ๅŸบๆœฌ่ฎก็ฎ—ๆœบๆŠ€่ƒฝ
  • ๅฎŒๆˆ่ฏพ็จ‹็š„ๅฅ‰็Œฎ็ฒพ็ฅž

ๆ— ้œ€ไบ‹ๅ…ˆ็š„ๆญฃๅผ่ต„ๆ ผใ€‚่ฏพ็จ‹่ฎพ่ฎกๆณจ้‡ๅฏ่ฎฟ้—ฎๆ€งใ€‚

่ฏพ็จ‹็Šถๆ€

ๆœฌ่ฏพ็จ‹ไธบ่Œไธšๅ‘ๅฑ•ๆไพ›ๅฎž็”จ็š„็Ÿฅ่ฏ†ๅ’ŒๆŠ€่ƒฝใ€‚ๅฎƒๆ˜ฏ๏ผš

  • ๆœช็ป่ฎคๅฏๆœบๆž„่ฎค่ฏ
  • ๆœช็ปๆŽˆๆƒๆœบๆž„็›‘็ฎก
  • ๅฏนๆญฃๅผ่ต„ๆ ผ็š„่กฅๅ……

ๆˆๅŠŸๅฎŒๆˆ่ฏพ็จ‹ๅŽ๏ผŒๆ‚จๅฐ†่Žทๅพ—็ป“ไธš่ฏไนฆใ€‚

ไธบไป€ไนˆไบบไปฌ้€‰ๆ‹ฉๆˆ‘ไปฌไฝœไธบ่Œไธšๅ‘ๅฑ•

ๆญฃๅœจๅŠ ่ฝฝ่ฏ„่ฎบ...

ๅธธ่ง้—ฎ้ข˜

ๆ˜ฏไป€ไนˆ่ฎฉ่ฟ™้—จ่ฏพ็จ‹ไธŽๅ…ถไป–่ฏพ็จ‹ไธๅŒ๏ผŸ

▼

ๅฎŒๆˆ่ฏพ็จ‹้œ€่ฆๅคš้•ฟๆ—ถ้—ด๏ผŸ

▼

WhatSupportWillIReceive

▼

IsCertificateRecognized

▼

WhatCareerOpportunities

▼

ๆˆ‘ไป€ไนˆๆ—ถๅ€™ๅฏไปฅๅผ€ๅง‹่ฏพ็จ‹๏ผŸ

▼

่ฏพ็จ‹ๆ ผๅผๅ’Œๅญฆไน ๆ–นๆณ•ๆ˜ฏไป€ไนˆ๏ผŸ

▼

่ฏพ็จ‹่ดน็”จ

ๆœ€ๅ—ๆฌข่ฟŽ
ๅฟซ้€Ÿ้€š้“๏ผš GBP £140
1ไธชๆœˆๅ†…ๅฎŒๆˆ
ๅŠ ้€Ÿๅญฆไน ่ทฏๅพ„
  • ๆฏๅ‘จ3-4ๅฐๆ—ถ
  • ๆๅ‰่ฏไนฆไบคไป˜
  • ๅผ€ๆ”พๆณจๅ†Œ - ้šๆ—ถๅผ€ๅง‹
Start Now
ๆ ‡ๅ‡†ๆจกๅผ๏ผš GBP £90
2ไธชๆœˆๅ†…ๅฎŒๆˆ
็ตๆดปๅญฆไน ่Š‚ๅฅ
  • ๆฏๅ‘จ2-3ๅฐๆ—ถ
  • ๅธธ่ง„่ฏไนฆไบคไป˜
  • ๅผ€ๆ”พๆณจๅ†Œ - ้šๆ—ถๅผ€ๅง‹
Start Now
ไธคไธช่ฎกๅˆ’้ƒฝๅŒ…ๅซ็š„ๅ†…ๅฎน๏ผš
  • ๅฎŒๆ•ด่ฏพ็จ‹่ฎฟ้—ฎ
  • ๆ•ฐๅญ—่ฏไนฆ
  • ่ฏพ็จ‹ๆๆ–™
ๅ…จๅŒ…ๅฎšไปท โ€ข ๆ— ้š่—่ดน็”จๆˆ–้ขๅค–่ดน็”จ

่Žทๅ–่ฏพ็จ‹ไฟกๆฏ

ๆˆ‘ไปฌๅฐ†ๅ‘ๆ‚จๅ‘้€่ฏฆ็ป†็š„่ฏพ็จ‹ไฟกๆฏ

ไปฅๅ…ฌๅธ่บซไปฝไป˜ๆฌพ

ไธบๆ‚จ็š„ๅ…ฌๅธ็”ณ่ฏทๅ‘็ฅจไปฅๆ”ฏไป˜ๆญค่ฏพ็จ‹่ดน็”จใ€‚

้€š่ฟ‡ๅ‘็ฅจไป˜ๆฌพ

่Žทๅพ—่Œไธš่ฏไนฆ

็คบไพ‹่ฏไนฆ่ƒŒๆ™ฏ
GLOBAL CERTIFICATE IN REGULATORY STRATEGIES FOR MEDICAL DEVICES
ๆŽˆไบˆ็ป™
ๅญฆไน ่€…ๅง“ๅ
ๅทฒๅฎŒๆˆ่ฏพ็จ‹็š„ไบบ
London School of International Business (LSIB)
ๆŽˆไบˆๆ—ฅๆœŸ
05 May 2025
ๅŒบๅ—้“พID๏ผš s-1-a-2-m-3-p-4-l-5-e
ๅฐ†ๆญค่ฏไนฆๆทปๅŠ ๅˆฐๆ‚จ็š„LinkedInไธชไบบ่ต„ๆ–™ใ€็ฎ€ๅŽ†ๆˆ–CVไธญใ€‚ๅœจ็คพไบคๅช’ไฝ“ๅ’Œ็ปฉๆ•ˆ่ฏ„ไผฐไธญๅˆ†ไบซๅฎƒใ€‚
SSB Logo

4.8
ๆ–ฐๆณจๅ†Œ
โ†’ ๆŸฅ็œ‹่ฏพ็จ‹