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