Training Programs

Our diverse range of Training programs helps professionals gain expertise and skills in various fields, ensuring their growth and success in the industry.

ISO 13485:2016 Lead Auditor Training Program

ISO 13485:2016 is the global standard for Quality Management Systems (QMS) in the medical device industry. This program trains professionals to audit, manage and enhance QMS effectively, ensuring compliance with regulatory requirements and safety standards.

Key Benefits

  • Strengthen Quality Systems: Build robust QMS for improved performance and global compliance.
  • Career Advancement: Open career opportunities in quality assurance, regulatory affairs, and auditing.
  • Leadership Skills: Gain the expertise to lead audits for certification bodies and organizations.

Course Highlights

  • Master ISO 13485: Deep dive into the standard’s core clauses and principles.
  • Audit Methodology: Planning, conducting, reporting, and post-audit actions.
  • Risk-Based Thinking: Evaluate risk-based compliance within QMS.
  • Practical Training: Mock audits, case studies, and real-world scenarios.
  • Global Regulatory Integration: Link ISO 13485 with global regulations (FDA, EU MDR).
  • Certification: Gain a globally recognized ISO 13485 Lead Auditor certification.

Program Details

  • Duration: 5 Days (40 hours)
  • Mode: Online or Classroom
  • Eligibility: Quality managers, regulatory professionals, auditors, any (working professionals & interested students)
  • Outcome: ISO 13485:2016 Lead Auditor Certification

Internal Auditor Training Program on ISO 13485:2016

Internal audits are key to maintaining an effective QMS in medical devices. This course empowers professionals to perform internal audits effectively, ensuring compliance with ISO 13485:2016 and improving QMS operations.

Key Benefits

  • Ensure compliance with ISO 13485:2016 and global regulations.
  • Enhance QMS effectiveness through gap analysis and corrective actions.
  • Build confidence to plan, execute and report internal audits.

Course Highlights

  • ISO 13485 Essentials: Deep understanding of the standard’s relevance to internal audits.
  • Audit Planning & Execution: Develop audit objectives, checklists, and schedules.
  • Effective Reporting & Follow-Up: Writing clear reports and ensuring corrective actions.
  • Practical Experience: Role-playing exercises and case studies.

Program Details

  • Duration: 3 Days (24 hours)
  • Mode: Online or Classroom
  • Eligibility: Quality professionals, managers, team members, working professionals & students
  • Outcome: ISO 13485:2016 Internal Auditor Certification

Indian Medical Device Regulations Training Program (IMDR)

Gain essential knowledge of India's medical device regulatory landscape, including the Drugs and Cosmetics Act and Medical Device Rules (MDR). This program helps professionals navigate approval processes and ensure compliance.

Key Benefits

  • Understand the Indian regulatory framework and market access.
  • Learn the medical device classification, approval, and compliance process.
  • Streamline regulatory submissions and documentation.

Course Highlights

  • Regulatory Overview: Key authorities like CDSCO and their roles.
  • Approval Process: Licensing, classification, and approval pathways.
  • Compliance & Documentation: ISO 13485 integration and post-market surveillance.

Program Details

  • Duration: 2 Days (16 hours)
  • Mode: Online or Classroom
  • Eligibility: Regulatory professionals, medical device manufacturers
  • Outcome: Certificate in Indian Medical Device Regulations

Awareness Training on ISO 14971:2019 (Risk Management for Medical Devices)

ISO 14971:2019 provides guidelines for managing risks in medical device development and lifecycle. This course teaches professionals how to identify, evaluate and mitigate risks to ensure compliance and safety.

Key Benefits

  • Understand risk management principles for medical devices.
  • Learn how to apply ISO 14971 in device development.
  • Enhance safety and compliance with international standards.

Course Highlights

  • Overview of ISO 14971: Understanding risk management processes.
  • Risk Assessment & Mitigation: Identifying, evaluating, and controlling risks.
  • Post-Market Risk Management: Handling risks during surveillance and updates.

Program Details

  • Duration: 1 Day (8 hours)
  • Mode: Online or Classroom
  • Eligibility: Quality managers, regulatory affairs professionals, product development teams
  • Outcome: ISO 14971:2019 Risk Management Certification
  • For More Information about trainings: Contact kcs@kiht.in | Ph: +91-8885092133