Direct to Consumer Testing
Let Avioq be your guide for Direct To Consumer (DTC) testing to get your project ready for the market.
We are ready to help you prepare for your:
- 510k submission
- CE Mark
- Health Canada
- Direct to consumer wellness market place
When you partner with Avioq, your project will benefit from our experience with FDA submissions, clinical trials, AI, and a wide range of expertise with assays, medical devices and instruments. Our services include:
- Prototype Design and Feasibility
- Clinical Studies and Stability Testing
- Risk Analysis
- GLP Precision, Repeatability, Reproducibility
- Device Safety and Performance
- cGMP Manufacturing and Scale Up
- Full-service assembly, packaging, warehousing and shipping available
Compliance
FDA 21 CFR Part 820
ISO 13485:2016
ISO 13485:2016
Design Control
Fully Developed QMS
FDA/ISO Audits
FDA/ISO Audits
Visibility
Secure Web Portal
Real-time Project Updates
Real-time Project Updates
Why Choose Avioq
We have extensive laboratory experience with blood, urine, fecal matter and oral fluid for testing and analysis.
Avioq has met all FDA 21 CFR Part 820 and ISO 13485:2016 requirements for document and purchasing controls, complaint handling, CAPA, non-conformances, design/production/process controls, quality audits, risk management and training.
Our Design Control and Quality Management Systems (QMS) are fully developed. Our facility has passed numerous inspections by FDA and ISO, as well as by external partners.
We provide each client with a secure data web portal to keep data organized and shared with the project teams in real time. The Avioq team moves quickly to keep your project on budget and on time.
Avioq gives you a custom solution to your most pressing challenges.