Development

Your R&D Breakthroughs Depend on Reliable, High-Performing Products and Services

Services we offer

  • Rapid prototyping
  • IHC assay development
  • Molecular assay development
  • Performance studies
  • Research studies
  • Product evaluation

FRAMEWORK

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.

Grow Your
Business

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

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