Healthcare and Medical Devices (ISO 13485) Training Courses

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

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.

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.

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.

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.

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.

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.

Develop your knowledge and skills in the process of implementing ISO 13485:2016 within an organization that provides medical devices or services to support medical devices.

Gain a better insight into the use of ISO 13485:2016 as the basis for a Quality Management System (QMS) implemented by medical device manufacturers.

To provide an understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for clinical evidence.

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.