Medical devices can save lives and being involved in the development of this type of equipment is rewarding, exciting, and challenging (1).
A project manager is responsible for making sure everything goes as planned, so it is a very important role when engaging in this type of development.
Project managers must have a particular skill set in order to be able to efficiently control medical device product development. The competencies needed for this role include the ability to initiate, plan and control the project, guide the team towards the end goal, and close the project. It means being familiar with the medical device development process and understanding best practices – it also requires the ability to work in accordance with several important standards and regulations.
Project managers who are unfamiliar with medical device development require further training in order to effectively fulfil their duties.
Project management training is desirable because it provides people with the information they need to succeed in their role. If a project manager is lacking in knowledge, it can lead to bad decisions, overspending, project delays, reduced quality, regulatory non-compliance, compromised safety, and disharmony in the team.
The project manager needs to be on top of things at every stage of the project, and this is not going to be possible without proper training.
Gantus Project Management for Product Development of Medical Devices Course
The Gantus project management for product development of medical devices course lasts four days, and it is most suitable for junior project managers as well as experienced project managers from other industries.
It covers all of the key areas, such as project models, regulatory requirements, normative standards (e.g. ISO 14971, IEC 62304, and IEC 62366), design control, product risk management, scheduling, human resources planning, estimating costs, and controlling a project. Those who complete the project management course are awarded a certificate at the end – all materials are provided along with a course book (A Guide to the Project Management Body of Knowledge).
Check out this wiki article on the design, development and classification of medical devices
Nathan Shaw holds a bachelor’s degree in Mathematics from the University of Bath but has since concentrated on pursuing research in worldwide environmental issues. With a particular interest in the science of Climate Change and it’s effect on developing nations, he plans to undertake a Masters of Research degree in September. Nathan is currently involved with local environmental organisations in his home county of Dorset, England - aiming to inform and educate people on the benefits of a sustainable life.