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Navigating IVDR as a small company is tough, but the right collaboration makes all the difference.

Prostatype Genomics

We received invaluable assistance from the consulting firm
GBA Key2Compliance

Watson-Marlow Flexicon

The training was a great success, not least because the flexibility from GBA Key2Compliance …

Envirotainer Engineering AB

DNA strings

“Thanks to thorough planning, hard work, strategic collaboration with both senior support from GBA Key2Compliance and support from our contract manufacturer, Prostatype successfully achieved IVDR certification—a major milestone for the company.

Katarina Sjöberg,
Head of RA/QA
Prostatype Genomics

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Flexicon FPC60 filling line application

“During a critical period for Flexicon, we received invaluable assistance from the consulting firm Key2Compliance, as we were without a Quality Manager for three months. /…/

I highly recommend GBA Key2Compliance to any company seeking professional, hands-on assistance during periods of increased need for quality management.”

Birgitte Drøhse Høgedal,
QA Manager
Watson-Marlow Flexicon

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RelEye® container from Envirotainer

”When we needed a common training in root cause analysis for personnel from both engineers, manufacturing teamleaders, purchasers and auditors we chose GBA Key2Compliance to deliver it for us.

The training was a great success, not least because the flexibility from GBA Key2Compliance to adjust the sessions for our needs, the possibility to add real-world cases to train on between the sessions as well as a truly competent and inspiring trainer/teacher. I can definitely recommend them for your next training event!”

Sofie Nordhamren,
Quality Director,
Envirotainer Engineering AB

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GBA Key2Compliance is our main consultant in the clinical development process.
The training was a great success
GBA Key2Compliance assists Watson-Marlow Flexicon with QA Manager

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