Approving medical devices can be a complicated and time consuming process with ever changing requirements.
The workshop is intended to guide you through the required processes and will cover the introduction of the new Medical Device Regulation and the clinical data requirements this brings, the key differences with the revised ISO 13485 and introduction to the Notified Body and the transfer process. We will conclude with a look at the IEC 60601 3rd and 4th editions including pitfalls and EMC requirements.
If you are involved with medical devices, particularly in design and development, compliance and approvals, quality and regulatory affairs or bringing products to market then this workshop will be invaluable. You will have the opportunity to meet with key experts from our medical team who will be on hand to discuss and advise on any aspect.
This workshop will cater for both active and non active devices and will be inclusive for anyone bringing medical devices to market. The morning session will include topics relevant to all classes of medical device with an emphasis on active medical devices in the afternoon.
Attending this workshop will help you to understand the compliance requirements for medical devices. This workshop will give you the best opportunity to get your compliant devices to market on time, every time.
Topics covered will include:
The new Medical Device Regulation, how it impacts you and your business With significantly expanded product scope, requirement for more stringent clinical data, identification of “qualified person”, implementation of unique device identification to aid supply chain traceability, more rigorous post-market surveillance and common specifications – we’ll tell you all you need to know!
Clinical Data The Medical Device Regulation will require device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with the risk associated with a given device. Device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks. These requirements are much more stringent than in the outgoing Medical Devices Directive and you need to be aware and prepared.
ISO13485:2016 The first revision to the standard since 2003 needed to address over a decade of changes in technology and regulatory requirements and to enable better integration with other management systems. This presentation will explain the key differences to ensure you are fully prepared and to help you avoid the pitfalls.
Introduction to the Notified Body and the transfer process Dealing with medical devices can be a regulatory minefield and rather daunting. Combine this with ever increasing scrutiny that Notified Bodies are required to perform in their role in the regulatory process and you can be left feeling rather isolated with a “mountain to climb”. Here we will explain how you can best and most easily interact with the Notified Body, we’ll explain what is required, the process, the timelines, the common mistakes and the pitfalls. We will also explain the transfer process when switching from one Notified Body to another.
IEC 60601-1 3rd Ed testing pitfalls The 3rd Edition of the standard has been with us for some time now but as with any complex test standard, there are inevitable mistakes and errors made in medical device design which only come to light at the testing stage where it is often too late with potential major cost and timescale consequences. We will demystify the testing process, explain how the risk management interacts with and drives the testing, finishing with a look at the common errors.
IEC 60601-1-2 4th Ed The 4th Edition introduces some key major differences and a new concept in the form of an upfront risk assessment where device manufacturers are required to identify potential EMC threats based on the device itself and the intended operating environment. With new tests and increased test levels to negotiate we will tell you all you need to know to successfully navigate the standard and successfully meet the requirements.