Development
Development & documentation according to ISO 9001 & ISO 13485 Compliant FDA 21 CFR 820.30
Your R&D breakthroughs depend on reliable, high-performing products and services. AMICONbio together with it associated partners offer a full line of custom assay development and validation services.
Our Development Services are available as both stand-alone services, and as defined integrated activity bundles. We offer customized solutions appropriate to client R& D programs, ranging from rapid prototyping to Milestone-driven project execution in an ISO 9001 & 13485 compliant design control process.
We perform all analytical and clinical performance studies required to compile your performance evaluation report (PER).
Our scientists have cross-functional, multi-disciplinary expertise in implementing integrated programs idependently or act as a competent resource for your own internal team.
We have a consistent track record of managing and executing projects of diverse complexities for a global clientele.
We are eager to add value to your organization.


We act as your strategic partner to help you to navigate the challenging and demanding MedTech & IVD industry.