CUSTOMER
Obtaining the required government certifications for a medical device is always a challenge. Especially when the COVID clock is ticking and you’re new to the medical devices industry. And that’s precisely what ZiggZagg, a Belgian 3D printing company, was up against in 2020…
CHALLENGE
In urgent need of qualitative knowledge and help
When COVID struck, Ziggzagg quickly adapted its 3D printers to help fix the shortage of nasal swabs. They knew perfectly well how to produce them, but proving their quality and compliance with government regulations was a whole different story…
Sound familiar? We can help.
With the help of QbD, we managed to comply with the strictest regulations very quickly. It’s been a wonderful collaboration.
APPROACH
FAMHP & CE certification and ISO13485 QMS
Enter Quality by Design, who created a strategy to convince the local FAMHP* to authorize the nasal swabs for Belgian hospitals. QbD also compiled a technical file to obtain a CE certificate to bring the swabs to the European market. Meanwhile, QbD also built an ISO13485-compliant Quality Management System together with ZiggZagg.
(*) FAMHP: Belgian Federal Agency for Medicines and Healthcare Products, also known as FAGG (Flemish) or AFMPS (French).
RESULTS
The green light
Thanks to QbD, Ziggzagg’s medical device was very quickly greenlit for use in both regions. And with its new QMS, Ziggzagg provides all current and future clients with guaranteed high-quality 3D printing services – a huge competitive advantage.
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