Healthcare and Medical Devices (ISO 13485) Training Courses

Learn how to design and develop medical devices to international quality standards such as ISO 13485, how to meet and keep ahead of medical device directive regulatory requirements, and gain knowledge of the CE Marking process. We also offer a wide range of specialist courses.

Our expert tutors are industry-leaders who have trained over 70% of the top 100 medical device companies globally, so you know you’ll be learning from the best.


Introduction to Risk Management for Medical Devices

Certified Medical Device Professional (CMDP) Training Course

₹42000

7 days classroom based training course

    In this 7 days program we will facilitate you develop your skills and understanding of the practicalities involved while preparing the Technical File that conforms to the requirements of Medical Device Directives. This includes introduction on Clinical Evaluation, Risk Management, harmonised standards applicable for Medical Device Directive (93/42/EEC) &
    In-vitro Diagnostic Device Directive (98/79/EEC) and effective submission of Technical File for CE Marking the Medical Devices and IVDs.

View details for Certified Medical Device Professional (CMDP) Training Course

Certified Pharma Quality Professional (CPQP) Training Course

₹40000

7 days classroom based training course

    In this 7 days training we will facilitate you develop your skills and understanding of the practicalities involved while preparing technical files is a very small part of the pharma industry. operations and Quality is what we should target. File is one of many aspects of pharma industry. We prepare them to face the critical world of phrma industry.

View details for Certified Pharma Quality Professional (CPQP) Training Course

Introduction to Risk Management for Medical Devices

₹10000

1 Day Classroom training course

    This course is designed to provide participants with an understanding of the impact that ISO 14971:2009 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485.

View details for Introduction to Risk Management for Medical Devices

ISO 13485 Medical Devices and CE Marking Trainings

ISO 13485:2016 Medical Devices Quality Management Systems (IRCA Certified) Auditor/ Lead Auditor Course

₹43000

5 days classroom based training course

    IRCA Certified Course (A18190)

    This course teaches the principles and practices of effective quality management systems and process audits in accordance with ISO 13485 and ISO 19011, “Guidelines for Quality and/or Environmental Management Systems Auditing.” Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results.

View details for ISO 13485:2016 Medical Devices Quality Management Systems (IRCA Certified) Auditor/ Lead Auditor Course

ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course

₹23000

2 days classroom based training course

    Learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.

View details for ISO 13485:2016 Medical Devices Quality Management Internal Auditor Training Course

Goods Distribution Practice for Medical Devices Training Course

₹12000

2 days classroom training course

    • Be equipped with the knowledge of medical devices fundamentals, GDPMDS requirements audit experience sharing and the implementation of GDPMDS in medical device manufacturing firms
    • Gain skills on how to prepare an execute an internal audit
    • Learn how to do corrective and follow up actions to improve your organization's GDPMDS efforts
View details for Goods Distribution Practice for Medical Devices Training Course