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 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 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 Practitioner Training is for those who want 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, strong understanding of both QSR 21 CFR 820 and ISO 13485 who want a shorter course covering 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).

This introductory course provides a practical overview of Good Documentation Practices (GDP) in the medical device industry.

This course introduces the fundamentals of Complaint Handling for medical devices, based on FDA Quality System Regulation (21 CFR Part 820.198)

This course provides an introduction to Product Recalls in the medical device industry, with a focus on FDA requirements under 21 CFR Part 7 and Part 806.

This course introduces the fundamentals of QMS Software Validation in the medical device industry, with a focus on conformance with ISO 13485:2016 and compliance with FDA expectations (21 CFR Part 11, 820.70(i)).

This course introduces the concept of Quality Culture in medical device organizations, using ISO 10010:2022 as a framework.

This course provides an overview of Japan’s regulatory framework for medical devices under the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW).

This course provides an overview of the Brazilian regulatory framework for medical devices governed by ANVISA.

This course provides an overview of the Australian regulatory framework for medical devices under the Therapeutic Goods Administration (TGA).

This course provides an overview of the Canadian Regulatory Framework for medical devices governed by Health Canada.

This course provides an overview of the United States FDA Regulatory Requirements for Medical Devices.

Introduction to Quality and Regulatory Affairs is for individuals or organizations looking for a concise, high-level introduction to the Medical Device Industry.

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

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

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

Introduction to ISO 14971 Training is for organizations looking for a short, high-level introduction for their staff.

Introduction to MDSAP Training is for organizations looking for a concise, high-level introduction for their staff.

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