Achevé Technology Inc. invites you to take advantage of our no-nonsense approach to achieve compliance with FDA regulatory and Good Manufacturing Practice/Quality System(GMP/QSR) requirements. We respect our client’s budgetary limitations and charge reasonably for our services. This is possible because we do not spend money on unnecessary expenses. We have a core of consultants, each having years of experience on medical device RA/QA compliance and development. We also have a network that can build a cohesive team for virtually any project size or skill required. We are fluent in both English and Chinese. |
We can help you on the following areas:
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| Regulatory: |
| 510(K) |
| PMA |
| Device Master File(DMF) |
| FDA registration |
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Quality Assurance: Audit Documentation Engineering: Mechanical/Optical/Electronic Tests Clinical trial support Simulation study Design/Manufacturing Reimbursement: Medicare Insurance
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