Diploma in Medical Device Regulations & Quality Management

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About Course

This specialized diploma course provides a comprehensive understanding of global medical device regulations and quality management systems. Designed for professionals in the medical technology and healthcare industries, the curriculum covers key regulatory frameworks such as FDA (U.S.), MDR (EU), ISO 13485, and risk management principles. Learners will gain practical knowledge in device classification, clinical evaluation, documentation, post-market surveillance, and quality assurance processes. The course prepares participants to ensure compliance, maintain product safety and effectiveness, and navigate complex regulatory landscapes across international markets.

What Will You Learn?

  • Become a Regulatory Expert: Demystify the intricacies of FDA 21 CFR Part 820, ISO 13485, MDR (EU) 2017/745, and other key global regulations. Learn to interpret
  • Master the principles of risk management, design controls, CAPA, and internal audits. Implement a QMS that not only meets regulatory requirements but also drive
  • In today's competitive market, regulatory expertise is a highly sought-after skill. This course equips you with the knowledge to advance your career, increase y
  • Benefit from expert-led video lectures, downloadable templates, and real-world case studies. We break down complex concepts into easy-to-understand modules, ens
  • Eliminate the fear of regulatory audits and product recalls. This course provides a clear, structured approach to compliance, giving you the peace of mind to fo
  • You will learn how to apply the knowledge to your specific situation, creating a tangible return on investment.

Course Content

Medical Device Regulations & Quality Management

  • Medical device regulation in Australia Vs USA, EU
    00:00
  • Medical device regulations in USA, EU and India
    00:00
  • Standalone Software as a Medical Device: Guideline and regulatory framework
    00:00
  • Documentation and Record Keeping in healthcare
    00:00
  • Smartwatches
    00:00
  • Technology in domestic violence
    00:00
  • Clinical errors by Paramedics
    00:00
  • EHR and Machine learning
    00:00
  • AI in healthcare
    00:00
  • Comprehensive HIPAA Overview
    00:00
  • HIPAA History
    00:00
  • HIPAA security rules
    00:00
  • HIPAA non compliance issues
    00:00
  • HIPAA PHI
    00:00
  • HIPAA EHI protection
    00:00
  • HIPAA Protection of ePHI
    00:00

London HeartbeatsZ Academy is a renowned group with >150 career advancement courses with rating of 4.3/5 on Udemy with students from 130 countries.

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