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Digital Health
SERVICES
Our significant and integrated experience enables us to implement industry practices to achieve results.
Regulatory Affairs
We lead and support regulatory projects covering IDE, 510(k), de novo 510(k), and PMA from end to end.
Quality Assurance
Implementing efficient and cost-effective quality systems based on QMSR, ISO 13485, and CLIA/CAP
EU IVDR and MDR
The AltaQ team has implemented strategies to successfully meet EU requirements for CE marking.
FDA QMSR
ISO 13485
AltaQ has expertise in integrating FDA QMSR and ISO 13485.
Validations
We help in developing and executing Analytical, Software, Process, and Facility Validations.
Software QA
We have extensive experience in developing software documentation covering FDA submissions.
Clinical Affairs
We develop and execute clinical validation protocols and plans for regulatory submissions.
30 years
Our team members have been serving the life science industry for more than 30 years.
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