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Quickly bringing a new COVID-19 medical device to market
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About ZiggZagg
Challenge
Approach
Result
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…
Approach
FAMHP & CE certification and ISO13485 QMS
Enter QbD Group, who created a strategy to convince the local FAMHP* to authorize the nasal swabs for Belgian hospitals. QbD Group also compiled a technical file to obtain a CE certificate to bring the swabs to the European market. Meanwhile, QbD Group 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).
Result
The green light
Thanks to QbD Group, 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.
Get in touch
Need help in bringing your medical device to market?
We can support you from concept to launch in the full lifecycle. Read here how we can help or contact us directly.
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