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RECENT ARTICLES
EU IVDR AND MDR
The AltaQ team has been helping diagnostic and device companies to achieve CE Marking for more than 25 years.
We have expertise integrating FDA and IVDR/MDR requirements to achieve FDA and CE Mark requirements.
EU-IVDR
In-vitro Diagnostics Regulations (IVDR) for CE Mark
IVDR
Gap Analysis
IVDR Gap Analysis will help us assess effort and timeline for IVDR requirements.
EU MDR
Medical Device Regulations (MDR) for medical devices - CE Mark
​ISO 13485
Integrating your quality system based on QSR, ISO 13485, and CLIA/CAP for CE Marking
Audits
We perform internal, external, and supplier audits to support your Quality System.
30 years
Our team members have been serving the life science industry for more than 30 years.
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