Medical Devices Training Courses

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Medical Devices Training Courses

Enhancing Regulatory & Quality Knowledge for Industry Professionals

At Isha’s GMP Consultancy, we provide highly interactive, scenario-based, and cost-effective training programs designed to keep Regulatory, Quality Assurance (QA), and Compliance professionals ahead of the ever-evolving medical device regulations.

Our flexible training options include:

  • On-site Training (At your facility)
  • Off-site Training (Workshops & Conferences)
  • Online Training (Virtual sessions)
Key Training Courses We Offer
ISO 13485:2016 Training Courses
  • Introduction to ISO 13485:2016 – Understanding the medical device QMS requirements.
  • Implementing ISO 13485:2016 – Practical guidance on setting up a compliant QMS.
  • Internal Auditor ISO 13485:2016 – Learn how to conduct internal audits as per ISO 13485.

European CE Marking Training Courses

  • Requirements for EU MDR (Medical Device Regulation) 2017/745 – Learn CE marking essentials.
  • Implementation of MDR for CE Marking – Understand clinical evaluation, technical documentation & post-market surveillance.
  • Implementation of IVDR (In Vitro Diagnostics Regulation) for CE Marking – Compliance requirements for diagnostic devices.

US FDA Regulatory Training

  • US FDA Regulation for Medical Devices – Understand 21 CFR Part 820 & pre-market submission requirements.
  • Country-Specific Medical Device Regulations – Learn about different global market regulations.

Medical Device Testing & Risk Management

  • ISO 14971:2019 – Medical Device Risk Management – Learn risk assessment & mitigation strategies.
  • Biocompatibility Testing (ISO 10993-1) – Understand biological evaluation of medical devices.
  • Safety & EMC/EMI Testing (IEC 60601-1 / IEC 60601-1-2) – Learn about electrical safety & electromagnetic compatibility.

Why Choose Isha’s GMP Consultancy Training?

  • Expert-Led Training by experienced regulatory & quality professionals.
  • Practical & Interactive Learning – Real-world case studies & examples.
  • Customized Training Solutions – Tailored to your company’s specific needs.
  • Certification & Compliance Support – Ensuring your team is audit-ready & fully compliant.

Contact us today to schedule a training session for your team!

Medical Device