Writing for Medical Devices

Detailed programme 1st day: 09:30 - 17:30
(09:00 registration)
2nd day: 09:00 - 17:30 09:00 Registration
09:29 Begin of day 1
09:30 Introduction & welcome
09:45 Barbara Grossman Overview of writing & editing documents

Substantive & technical aspect, including:

Logic, text flow & wordiness, as well as accuracy

Details such as language use, abbreviations & acronyms

Preparing a clear message for the intended reader

Authorship including basic principles

11:00 Coffee break
11:15 Kirsten Sander Medical writing & the clinical evaluation of a medical device

Introduction to the European medical device regulations & guidelines

How the clinical evaluation & clinical evaluation report (CER) are related & the role of the medical writer

12:30 Lunch break
13:30 Medical writing & the clinical evaluation of a medical device (continued)

Clinical evaluation vs CER

Required knowledge base

Authorship

The varying responsibilities of the medical writer

14:30 Barbara Grossman Writing regulatory documents

Do different audiences & documents require different approaches?

Corresponding with the authorities

15:45 Coffee break
16:00 Barbara Grossman Aspects of English

Common errors in English that should be avoided

Brief overview of key punctuation points affecting meaning & readability

17:30 End of day 1
08:29 Begin of day 2
08:30 Kirsten Sander Structure & content of the CER

Structure of the CER

Essential sections - What goes where?

Content of the CER

'State of the art' - the clinical setting

'Performance & safety of the medical device'

'Consider the reader' - what the notified body expects

Source documents & how to acquire them

Pre-clinical data: mode of action & biocompatibility

Clinical data: performance and safety

Technical documents

Clinical guidelines & the solicited clinical expert statement

Industrial & commercial standards such as ISO

Safety data

10:45 Coffee break
11:00 Barbara Grossman Improving readability - being kind to your reader

Structuring texts

How perfect do regulatory documents need to be in terms of language?

12:30 Lunch break
13:30 Kirsten Sander CER: systematic literature searches

Effective search strategies

Which databases to use

How to use them

Group exercise

Effectiveness of search strategies - a review of the published evidence

Balancing effort (& cost) against outcome

14:15 Kirsten Sander CER case study

At least one example on how to produce a CER

Deciding on what source data is needed

Finding the source data

15:30 Coffee break
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