This training 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 and also it serves to facilitate global alignment for Medical Device quality management systems.  

This course is designed to provide you with an understanding of ISO 14971:2019 and the impact it has on the design, development, manufacturing and lifecycle of medical devices.  It will also provide medical device manufacturers with knowledge of how ISO 14971:2019 links with the ISO 13485:2016 standard and the MDR 2017/745.  Practical activities throughout the day will give you the opportunity to apply your skills, implementing risk management activities so that these can be embedded within the organization on completion of the course. 

The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.

Learn about the key requirements of risk classification under the MDR, gain a better understanding of the risk classification rules, the need to classify and why the intended purpose of a device is important.

The Medical Devices Regulation (MDR) is the legislation detailing the requirements that manufacturers must meet to place medical devices on the market in the European Union.

Learn some key requirements about Annex VII of the MDR and gain a better understanding of why notified bodies may be seen to behave differently and in a much more detailed way than what organisations may have previously experienced.

The Medical Devices Regulation (MDR) is the legislation detailing the requirements, that manufacturers must meet to place medical devices on the market in the European Union.

Learn about the various economic operators and their obligations according to the MDR.

The In Vitro Diagnostic Regulation (IVDR), is a comprehensive set of European Union (EU) rules that govern the production, sale, and distribution of in vitro diagnostic devices. These devices play a crucial role in analyzing human samples, like blood or tissue, outside the body, providing essential data for medical diagnoses and treatment planning. This short course will focus on how the IVDR prioritizes safety, effectiveness, and the highest standards of public health within the EU.

This course introduces you to the key requirements of the IVDR. IVDs will now be classified according to their risk using a new rule-based system. The majority of IVDs will be subjected to independent assessment of their conformity to the Regulation by a Notified Body and will require third-party certification for the first time.

The In Vitro Diagnostic Devices Regulation (IVDR 2017/746) is the legislation detailing the requirements which manufacturers have to meet to place in vitro diagnostic devices on the market in the European Union. This training course aims to offer guidance on implementation of the requirements stipulated in the IVDR into your business.

This course will help you understand the key requirements and concepts of the European Medical Devices Regulation; communicate the impact of the key requirements introduced by the MDR to your organization.

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.

To address the requirements of Medical Device Directives, manufacturers must demonstrate their commitment to the safety and quality of their medical devices. This course enables a clause by clause understanding of ISO 13485:2016, which provides an effective solution to meet the comprehensive requirements of an effective QMS. 

This course prepares you for the implementation of ISO 13485 in your organization so that you can further pursue certification to show confidence of compliance to the standard towards stakeholders.

Confidently guide your organization towards preparation for ISO 13485:2016 certification thru frequent internal audits to check on your system's readiness. Our tutors will also cover auditing best practices, tips and tricks during the session.

Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO 13485:2016.

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.
It helps medical device professionals understand how ISO 14971:2019 can improve their business and risk management efforts.

This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices, in line with the European Medical Device Regulations (MDR) and ISO 13485:2016 requirements in Europe. The aim of the course is to enable manufacturers to know what process validation evidence is necessary to demonstrate the manufacturing process is validated.

This two day training course will give you a good understanding of the FDA 21 CFR 820, Quality System Regulation (QSR).

The medical device industry is highly regulated due to the product risk to health, and one of the requirements is to establish and maintain a quality management system. Although the rest of the world complies with ISO 13485 standard, the United States requires compliance to the 21 CFR 820, Quality System Regulation (QSR).

The ability to identify opportunities for improvement is an important skill for an internal or lead auditor. It could involve a reduction in incidents, improved processes or increases in performance.