EU IVDR and MDR

Extensive experience with In Vitro Diagnostics Regulations (IVDR) and Medical Device Regulations (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,

In-vitro Diagnostics Regulations (IVDR) for CE Mark

IVDR Gap Analysis will help us assess effort and timeline for IVDR requirements.

Medical Device Regulations (MDR) for medical devices - CE Mark

Integrating your quality system based on QSR, ISO 13485, and CLIA/CAP for CE Marking

We perform internal, external, and supplier audits to support your Quality System.

30 yrs

Our team members have been serving the life science industry for more than 30 years.

100%

return and retention rate

We are proud that we are able to build and trust with our clients and retain of clients for multiple years.