Case Studies.

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Forte Medical

Creating Instructions for Use

that are ‘Easy Peezy’

Luto had the pleasure of working on a set of new Instructions for Use (IFU) for a medical device called ‘Peezy’. Created by Forte Medical, Peezy is a device that aids the user in giving a midstream urine sample. Our challenge was to re-design the instructions for use as part of the packaging, ensuring they were clear and simple, and reflected the simplicity of the process.

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Macmillan Cancer Support

Reviewing and refining cancer information booklets

We approached this project carefully, as it was our very first undertaking of this scale. We studied our client’s business to create a focused and effective solution - and then watched it grow. We loved working with this client, and look forward to collaborating together on many more successful projects in the future.

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Risk Management Planning

Are RMP summaries fit for purpose?

Increasing numbers of regulatory documents are being made available as public or lay summaries. In the European Union (EU), one such document is the Risk Management Plan (RMP), which describes the identified potential risks of a medicine and how these risks will be managed.  It is similar to the US ‘REMS’ (Risk Evaluation and Mitigation Strategy).

A ‘typical’ RMP summary from the EMA website was selected shortly after they were first published in Spring 2014.  The aim was to determine how readable and understandable the summary was. Two rounds of testing were undertaken with members of the public.