Technical writing and editing
IT and medical devices
Technical writing and editing in IT
I taught technical writing for two years at the Georgia Institute of Technology in Atlanta in the late 90s before writing professionally myself. I then started freelancing as a technical writer and editor.
Over the years I have served as Technical Writer and Editor for such organisations as:
- IBM (in the US and EMEA)
- Philips
- Agilisys (now Infor)
- ASML
- ITS Global at KPMG International
IBM Knowledge Factory (US, EMEA)
I joined IBM’s Knowledge Factory, first as a technical writer, then as senior editor, in Atlanta in 1998. I worked on a range of writing and editing assignments, most notably as Senior Editor on a project for the World Intellectual Property Organization (WIPO): as the sole editor on the project, I edited more than 800 pages of documentation on WIPONET, a VPN network that IBM had built for WIPO and that connected Member States to servers at the organisation’s headquarters in Geneva.
Alongside my editing role, I was also asked to coach individual technical writers in the do’s and don’ts of drafting and in adapting their style to meet clients’ needs.
In 2000 I was asked to create one-day training course on the Knowledge Factory method, and to deliver it to a new team of technical writers who had been brought in to create a number of training modules on a major project for Électricité de France. I produced, and delivered, the training in French.
ASML
ITS Global @ KPMG International
Style Guides I have Produced
Over the years I have overhauled or created style guides for a number of major organisations. For instance:
- I created the IBM Knowledge Factory Style Guide for IBM, and trained staff both in Atlanta and Paris on the conventions and on the do’s and don’ts of drafting
- At management’s request, I wrote a new version of the OPCW Style Guide from scratch
- For ITS Global at KPMG international, I created from scratch a Guide to Producing Clear, High-Quality Documentation
- In the context of a project at Philips that edited the text of the company’s new, sleeker intranet at Philips, I was asked to produce this Guide to Gathering Content. (The Project Manager for the migration effort, Claire Dorel-Watson, published this LinkedIn post on the project, which was completed on time and within budget, and even won an award.)
Technical writing and editing in the medical-device space
- Elekta
- Sakura Finetek Europe
Elekta
Sakura Finetek Europe
- Creating IVDR and other technical documentation, including a number of standard operating procedures (SOPs) required under the IVDR
- Creating or adapting and maintaining documentation templates, with input from QARA and other departments:
- Instructions for use
- Annex I: General Safety and Performance Requirements
- Annex II “backbone”
- Creating instructions for use based on materials from OEMs and on specifications in safety data sheets
- Liaising as needed with subject-matter experts from QARA and other departments in Central Office
- Editing and finalising SOPs required under the IVDR
- Editing and finalising SFE IVDR and other technical documentation other than materials provided by OEMs:
- Documents produced in-house
- Documents submitted by Qserve, a consultancy with expertise in IVDR certifications
- In the later going, establishing and maintaining a definitive list comprising:
- Product/device and product-group names
- Statements of intended purpose
- Device descriptions
- Reviewing claims in the Marketing Department’s claims library for clarity and accuracy
- Helping gather and establish requirements for the IVDR document repository in SharePoint
- Uploading to SharePoint and, as needed, submitting for approval:
- Documents produced in-house
- Documents submitted by Qserve
- OEM documents
- Editing and finalising, for the SmartConnect cobot, the Risk-Management Plan and the Risk-Management Report
BAAT Medical
In early 2017 I did a short stint as Technical Writer for BAAT Medical, a small Dutch company that designs prosthetic devices, drafting new submissions in support of its application for ISO 13485:2016 certification. According to the ISO, this standard “specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).”
