Contract manufacturing operations for medical devices and IVDs — design transfer, GMP-compliant production, quality release, and lifecycle support.
Why teams choose us
A flexible CMO engagement that adapts to your design, volume, and timeline.
BOM, drawings, process specs translated into a production-ready package.
Three-batch validation, IQ/OQ/PQ, cleaning validation per ISO 13485.
Cleanroom manufacturing across our partner facility network.
In-process and final QC, batch records, certificate of analysis.
Device master record, history files, traceability matrices.
Change control, deviation handling, ongoing performance monitoring.
A measured tech-transfer and ramp-up.
Design review, volume planning, capability matching, costing.
Quality agreement, supply agreement, IP and confidentiality terms.
Specs, BOMs, drawings, process documents transferred and validated.
Three pilot batches with full validation documentation.
Production scaling to target volumes with QC release per batch.
Quarterly business reviews, continuous improvement, change control.
Pre-audited ISO 13485 facilities across India with diverse capabilities.
“We were matched with a contract manufacturer that fit our quality standards, and the technology transfer went smoothly.”
Faster design transfer than the typical industry timeline.
Full audit trail, batch records, and traceability for every unit produced.
Segregated production with appropriate QMS partitioning for multiple clients.
Manufacturing partnership established
A healthcare company outsourcing production of diagnostic products needed to select a qualified manufacturing partner while managing quality, regulatory, and technical-transfer concerns. We identified suitable partners, ran compliance assessments, supported technology-transfer documentation, and established quality agreements and oversight.
Qualified
Manufacturing partner
Assessed
Compliance review
Transferred
Technology & docs
Consistent
Product quality
Quick answers about scope, timelines, and how this engagement runs.
Ask us directlyWe coordinate a network of pre-audited ISO 13485 partner facilities. You get factory-quality results without us being a single point of failure.
Robust NDAs, segregated production, limited-access design documentation, and quality agreements that explicitly retain IP ownership with you.
Varies by device. Disposables generally need higher minimum volumes than active devices. We match your volume to the right facility capability during scoping.
You retain the license. Bio-State coordinates the technical file inputs from the CMO. We can also act as your full regulatory partner if you don't have in-house regulatory.
Yes — quality agreements and tech transfer packages are structured so you can move production to another facility if needed.
Tell us your device, volume, and timeline. We'll match you to the right CMO partner within two weeks.