Medical Devices

Our integrated regulatory, quality,
and clinical solutions for small
and medium sized companies

Implementing efficient and cost-effective quality systems based on QMSR, ISO 13485, and CLIA/CAP.

We lead and support regulatory projects covering IDE, 510(k), de novo 510(k), and PMA from end to end.

AltaQ has expertise in integrating FDA QMSR and ISO 13485.

We help in developing and executing Analytical, Software, Process, and Facility Validations

AltaQ team has implemented strategies to successfully meet EU requirements for CE marking.

We develop and executes clinical validation protocols and plans for regulatory submissions.

Our experience is our key asset and building trust is our goal!

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.