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

ISO 14971:2019 Risk Management Requirements for Medical Devices Virtual Online Training Course On Our Connected Learning Live Platform >

This one-day intensive course enables greater understanding of the impact that ISO 14971:2019 has on the decision-making process when manufacturing medical devices. This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor.

₹11000

1 Day Online training course

Introduction to Risk Management for Medical Devices >

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.

₹11500

1 Day Classroom training course


ISO 13485 Medical Devices and CE Marking Trainings

ISO 13485:2016 Introduction Virtual Online Training Course on Our Connected Learning Live Platform >

This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor.

₹9000

1 Day Online training course

Implementation of Medical Device Regulation for CE Marking Virtual Online Training Course On Our Connected Learning Live Platform >

This course will help you to implement the requirements of European Medical Device Regulation (MDR) to obtain and maintain CE marks for your product, giving you access to a market with 500+ million people. This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor.

₹26000

3 Days Online training course

ISO 13485:2016 Internal Auditor Virtual Online Training Course On Our Connected Learning Live Platform >

Learn the principles and practices of effective quality management systems process audits in accordance with the ISO 13485:2016 and ISO 19011:2018. This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor.

₹21000

2 Days Online training course

ISO 13485:2016 Medical Devices Lead Auditor Virtual Online Training Course On Our Connected Learning Live Platform >

You’ll acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance. This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor.

₹39500

5 Days Online training course

ISO 13485:2016 Implementation Virtual Online Training Course On Our Connected Learning Live Platform >

This two-day course has been designed to provide participants with the knowledge and process steps to enable them to effectively implement a quality management system in line with the requirements for ISO 13485:2016. This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor.

₹17000

2 Days Online training course

Implementation of the In Vitro Diagnostic Device Regulation for CE Marking Virtual Online Training Course on Our Connected Learning Live Platform >

To help implement the requirements of the European In Vitro Diagnostic Device Regulation (IVDR 2017/746) to obtain and maintain the CE mark for your product. This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor.

₹26000

3 Days Online training course

MDD to MDR Transition Virtual Online Training Course On Our Connected Learning Live Platform >

This course introduces you to the key changes from the European Medical Device Directive (MDD) to the new European Medical Device Regulation (MDR). This training content will be delivered via BSI’s Connected Learning Live Platform as a virtual classroom with the BSI tutor.

₹11000

1 Day Online training course

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

IRCA Certified Course (18190)

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.

₹49500

5 days classroom based training course

ISO 13485:2016 Medical Devices Quality Management Internal Auditor 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.

₹26000

2 days classroom based training course

Goods Distribution Practice for Medical Devices 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
₹13000

2 days classroom training course

Medical Device Single Audit Program (MDSAP) Fundamentals and Readiness Virtual Online Training Course on Our Connected Learning Live Platform >

Upon completion of this training, delegates will be able to support their organization to maintain compliance to ISO 13485 and jurisdiction requirements in the countries engaged in the MDSAP program.

₹23000

2 Days Online training course