Introduction

Portfolio of devices requiring a refresh of their operative manuals

Aim

Review, edit, modernise, and ensure regulatory compliance.

Method

This work represents a frequent form of engagement and involves the review, editing, and potential total re-write, of company communications. These may be in-house, business-to-business, or for end-users/prescribers. The process starts with a deep dive to understand the specific product and use-case. This is a team-based approach and involves anyone from clinical affair management and the sales team, to design engineers and end-user. We look at logical document flow, clarity and relevance of language, layout and graphical representation, and finally, where there may be representations, claims, or indications for use, we work with compliance teams to ensure that the content satisfies regulatory and legal requirements.

Conclusion

Delivered with significant amendments protecting the documents from audit concerns and with benchmarked qualities positioning the documents favourably in comparison to competitors.