Whether there are gaps in your QMS, you’re facing an audit (FDA/MDSAP/GMED), need IUV support or you simply want to improve the quality of your products – our experienced quality experts are here to help.
Advantu specializes in custom device and hospital system software engineering services. We are experts in advanced software technologies for the entire software stack, supporting new product design and development, as well as supporting sustaining activities.
Are you in the middle of crunch time? Do you need additional support for a new project? Our software quality engineers have decades of verification and validation experience. Medical devices are in our DNA.
During preparation for our GMED CE Mark regulatory submission, we enlisted Advantu to conduct a Design History File (DHF) gap analysis and ensure critical elements were remediated to the Medical Device Regulation (MDR) standard.
With poise and balance, while under duress and an incredibly tight timeline, Advantu admirably delivered more than expected. We highly recommend Advantu for any Quality & Engineering needs.
Advantu provided resources for software quality assurance and testing support for a Medical Device & Physician/Patient Portal interface system. Clarify was able to successfully release their product with the highest quality and reliability.
We wanted to update and improve our Intended Use Validations at Hawkins for both COTS and Custom developed applications. Included in this effort was the Electronic Signature (21CFR Part 11) validation of our internally developed system supporting our QMS. We brought Advantu’s Process Experts on board.
Advantu’s team was extremely professional, knowledgeable and enjoyable to work with. Their deliverables were completed professionally and provided the foundation for the next steps in our IUV process. We look forward to our continued relationship with Advantu’s experts.
We wanted to add a new DNA Synthesis Instrument to our GMP workflow, so we brought Advantu’s Process Experts on board to conduct the appropriate analysis, develop the plan and spearhead the implementation. I wholeheartedly recommend them for any Regulatory and or Quality Process support you may need.