At Baymar, we’re dedicated to providing expert fractional services tailored to the In Vitro Diagnostic (IVD) instrument market. With a focus on reagent and assay support, as well as regulatory services, we help clients navigate the complex world of IVD development and compliance.
Navigating the ever-evolving landscape of IVD instrument regulations is no small feat. Our Fractional Regulatory specialists can provide you with a clear assessment of the landscape and how to navigate it.
Regulatory strategy development
Submission preparation and review
Compliance with FDA, CE mark, and international regulations
Quality management system advice
Risk assessment and mitigation
Our team specializes in reagent and assay support for IVD instruments. We understand the pivotal role that high-quality reagents and assays play in diagnostic accuracy. Our services in this area include:
Reagent quality assessment
Assay troubleshooting and optimization
Supplier evaluation and selection
Assay transfer and validation