The client
Develops, manufactures and supplies medical devices aids to support people with disabilities. The
company’s product range is designed to be used between patients and caregivers and are used by
organisations across Europe’s health and social care sector.
“We are one of the leading European companies in this sector,” explains the client, R & D Director.
The challenge
In May 2021, the EU regulations which govern medical devices changed. For the client, that change
had a potentially dramatic impact on the business.
“The new Medical Devices Directive (MDD) meant we needed to have every single product manual
translated into the language of the territory in which it is sold,” says the client. “Across Europe there
are up to 12 languages, so we needed up to 100 manuals translating into 12 languages. In practice,
for example, that meant 75 product manuals needed to be translated into Czech and Slovakian. 26
needed translating into Polish. The fact is, we wouldn’t be able to sell our equipment if we didn’t
have the right documentation. We needed these manuals to be legally compliant.
“We needed someone to organise the logistics around all this. It was a lot of work.”
Working with Lucy
There was more to creating the new documentation than translation. Lucy worked with the client
engineering team to update each manual’s content. Branding had to be consistent across the
portfolio of manuals. Data, text and images needed aligning within the design template.
Lucy built a clear picture of what translations were needed and launched negotiations with external
translation companies to create the new versions.
“How Lucy managed the collaboration between all the different parties for translation was no mean
feat,” says the client. “I particularly liked working with Lucy because I didn’t have to worry about the
job and I didn’t need to check everything. I was thankful she could coordinate it all and take the job
off my shoulders. She is very good at handling communications and dealing with project logistics.”
Throughout the project, content needed to be amended at the request of the internal regulatory
department and/or local authorities, so a large project grew larger still, eventually spanning ten
months.
Adding value
Lucy sourced local translators to translate manuals for their own countries. It was a move that saved
a significant amount of time and money. She also negotiated a big discount with a translator who
already worked with the head office in England, further reining in project costs.
By setting up a SharePoint database and new folder system, Lucy enabled the client’s staff to find
and view the up-to-date versions of the manuals in one place. The move also made it easier to
update the company website with the new content.
Lucy is…
“… someone who is a good communicator,” says the client. “She understands the complexity of the
project and is not afraid to work hard. She gets the job done.”
Lucy says:
The client’s challenge is one that any medical product supplier with a CE mark will face within
Europe. Without correctly translated product collateral, you risk fines and product recalls.
Fortunately, my project management skills and industry experience gained with AstraZeneca,
together with my understanding of English, meant I was able to help the client.
One of the aspects of being able to deliver this project was to work with Adobe InDesign which I have
now gained a huge knowledge and knowhow of this programme. This is something the client has no
knowledge of which is why my expertise was needed.
Key to the project’s success was defining a clear, setlist of manuals for translation and building the
relationships that enabled me to collaborate effectively with translators, local distributors and the
client.
