Medical Device Quality Assurance & Regulatory Training

This course 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, in accordance with ISO 19011 and ISO IEC 17021-1.

This course 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 Medical Device Regulation (EU 2017/745) in accordance with ISO 19011 and ISO 17021 as applicable.

This course 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 & Regulatory Professionals who are new to the Regulation.

This course 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.

This course 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.

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

This course is for anyone 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 (21 CFR Part 820).

This course that provides a comprehensive overview of the international standard for risk management for medical devices. It has has been specifically designed for Quality & Regulatory Professionals in the Medical Device Industry.

This course is for anyone who wants the knowledge required to understand the IMDRF Medical Device Single Audit Program (MDSAP) and the MDSAP audit approach.

This course 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).

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

This course is for those looking to understand the clinical evaluation requirements under the EU MDR (2017/745)

This course provides clarity on the role and responsibilities of the Authorized Representative under Article 11 and Article 12 of the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR).

This course provides an in-depth look at both the SDLC and IEC 62304 (2006).

This course provides a foundation for understanding the regulatory landscape for medical device software development.

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

This course will cover in detail the requirements of 21 CFR Part 11, the US regulation covering Electronic Records and Electronic Signatures.

This course is for anyone that wants refresh or enhance their ability to complete internal audits of part of their Management System (MS) whether its against ISO 9001, ISO 13485, ISO 14001, ISO 45001 or ISO 17025.

This course is for anyone that wants to understand the principles and practices of conducting management system audits in accordance with ISO 19011 (2018).