Medical Device Quality and Regulatory Affairs (QARA) Training

ISO 13485 Lead Auditor Training is for anyone that wants to gain the knowledge and skills required to perform full system first, second and third-party audits based on ISO 13485 2016, in accordance with ISO 19011 and ISO IEC 17021-1.

EU MDR Lead Auditor Training will provide learners with the knowledge and skills required to lead audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU MDR 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.

MDSAP Auditor Training provides learners with the knowledge and skills required to understand and complete an audit against the IMDRF Medical Device Single Audit Program (MDSAP) for medical device quality management based on ISO 13485 and international regulatory bodies medical device regulations.

EU MDR Requirements Training for Practitioners takes you through the new European Medical Device Regulation (2017/745), not just from an industry perspective, but also from a Notified Body perspective. It has been specifically designed for Quality and regulatory Professionals who are new to the Regulation.

EU MDR Internal Auditor Training is for existing ISO 13485 Internal or Lead Auditors seeking the knowledge & skills to perform internal audits of medical device quality management systems (MD-QMS) against the European Union’s Medical Device Regulation (EU MDR 2017/745) in accordance with ISO 19011.

EU IVDR Requirements Training for Practitioners takes you through the new European In Vitro Diagnostic Regulation (2017/746), not just from an industry perspective, but also from a Notified Body perspective. It has been specifically designed for Quality & Regulatory Professionals who are new to the Regulation.

EU IVDR Lead Auditor Training will provide learners with the knowledge and skills required to perform audits of medical device quality management systems (MD-QMS) against the European Union’s In Vitro Diagnostic Regulation (EU IVDR 2017/746) in accordance with ISO 19011 and ISO 17021 as applicable.

FDA QMSR Training is for Practitioners and Auditors who wants to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality Management System Regulation (Revised Part 820).

FDA QMSR Transition Training is for those with an existing understand of the QSR and ISO 13485 who want to understand the key changes and new requirements introduced by the Quality Management System Regulation (QMSR).

Post Market Surveillance (PMS) Training is for those looking to master the post market surveillance requirements under the EU MDR 2017/745

Post Market Surveillance (PMS) Requirements Training is for those looking to understand the fundamentals of post market surveillance requirements under the EU MDR 2017/745

Clinical Evaluation Training is for those looking to understand the clinical evaluation requirements under the EU MDR (2017/745)

ISO 13485 Internal Auditor Training is for anyone who wants to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485.

MDSAP Requirements Training provides learners with the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.

CAPA Training for Medical Devices covers CAPA requirements, common root cause investigation tools, and how to prepare for an inspection of the CAPA process.

CAPA Requirements in Medical Devices Training provides a comprehensive overview of CAPA requirements, common root cause investigation tools, and the CAPA process in Medical Devices.

Advanced Risk Practitioner Training provides a comprehensive overview of ISO 14971 and workshops with an experienced Practitioner to help you transform the knowledge to practical skills you can immediately apply back at your place of work.

ISO 14971 Training for Practitioners and Auditors provides a comprehensive overview of the international standard for risk management for medical devices, ISO 14971.

ISO 13485 Requirements Training is for anyone looking to gain a comprehensive understanding of the core requirements of ISO 13485 and this highly interactive course can be completed anytime, anywhere (24/7).

Person Responsible for Regulatory Compliance (PRRC) Training provides clarity on the role and responsibilities of the PRRC introduced under Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

Advanced EU MDR Practitioner Training is for Quality & Regulatory Professionals who want comprehensive training on the European Medical Device Regulation (EU MDR 2017/745) that is a hybrid of eLearning and Live Classes.

Advanced EU IVDR Practitioner Training is for Quality & Regulatory Professionals who want comprehensive training on the European In Vitro Diagnostic Regulation (EU IVDR 2017/746) that is a hybrid of eLearning and Live Classes.

ISO 13485 and FDA QSR 21 CFR Part 820 Requirements is for Practitioners & Auditors who want to understand the requirements, including similarities, differences and key aspects of both the ISO 13485 standard and the FDA Quality System Regulation (QSR 21 CFR Part 820).

FDA QMSR Essentials Training is for individuals or organizations looking for a concise, high-level introduction to the FDA’s Quality Management System Regulation (QMSR).

EU IVDR Essentials Training is for organizations looking for a concise, high-level introduction for their staff.

EU MDR Essentials Training is for organizations looking for a concise, high-level introduction for their staff.

ISO 13485 Training is for organizations looking for a concise, high-level introduction for their staff.