Medical Equipment Manufacturers

As a medical equipment manufacturer you will be familiar with operating in a highly regulated market that places the utmost importance on product quality and safety.

You understand that for medical equipment that incorporates radio devices, it is necessary to have regard both to the regulations that apply to the use of radio as well as to the impact that the use of radio communications has on the regulatory requirements for medical devices: specifically, product safety. In this context it is necessary to consider the impact of communication errors on product performance and it may also be necessary to mitigate the risks posed by hackers.

It is reasonable for regulatory standards to lag behind the state of the art because it takes time to balance the benefits associated with the use of new technologies against the risks. This can be a problem for medical companies developing innovative and potentially disruptive technologies.

With our deep understanding of the regulatory space, of product engineering and of state of the art test methodologies, we can help you to engage with the regulator in order to develop an approvals strategy for your chosen markets. We can help your engineers to capture regulatory design requirements, and we can inform your failure mode effects analysis by identifying the key risks associated with environmental electromagnetic phenomena and with the use of radiocommunications devices.

We can work with your engineering and regulatory teams to design robust, effective test protocols that clearly describe what testing is required and how performance will be monitored. And we will provide support to ensure that these protocols are correctly executed at the test laboratory.

You will appreciate our tenacious focus on delivery and on hitting key milestones. Our mission is simple: to help you to succeed.

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