Learn how to design and develop medical devices to international quality standards such as ISO 13485, how to meet and keep ahead of medical device directive regulatory requirements, and gain knowledge of the CE Marking process. We also offer a wide range of specialist courses.
Our expert tutors are industry-leaders who have trained over 70% of the top 100 medical device companies globally, so you know you’ll be learning from the best.
This intensive five-day course will teach you how you can effectively lead a team of auditors and how to identify gaps in a medical devices quality management system. This course is recommended for consultants.
Learn about the various clauses of the standard and understand the implications behind medical devices quality management. Allow our medical devices experts to guide you in unravelling the standard, and bring Medical Devices Quality Management to your organization.
There are significant changes in the European legislation applicable to IVDs. The IVD Regulation has replaced the IVD Directive, which will impose new requirements on manufacturers and other economic operators.
To give delegates a good understanding of what is needed to prove a manufacturing process is validated, as required by the Medical Devices Directive and ISO 13485:2016. The meaning of process validation terminology will be explained in detail and how the method is used. One validation technique will be explained.