Medical device and in vitro medical device companies need to prove their products are safe and compliant to secure their CE and UKCA conformity marks.
But complex, shifting legislation and the impact of Brexit have made cracking the EU and UK markets a tricky task.
Manual quality, siloed processes and murky visibility make lasting compliance an onerous, time-consuming and energy-sapping burden.
Qualio's fully integrated eQMS software arms medical device companies with the tools they need for confident, long-term adherence to EU MDR/IVDR and UK MDR requirements.
Digital workflows, cloud-based documents and a single source of truth make it easy to connect your workforce to a collaborative quality culture.
CE and UKCA marks become a natural byproduct, not a stressful target.