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Capability

CAPA management

Suppliers
2
States & provinces
2
Countries
1

2 capa management suppliers across 2 states and provinces in 1 country. Profiles show capabilities, materials, certifications, and facility locations so you can compare shops and build a shortlist.

Suppliers

BEANSTOCK VENTURES

SAN DIEGO, CA

BeanStock Ventures is a San Diego-based regulatory consulting firm for medical devices and digital health, founded by engineers-turned-regulatory experts with over 25 years of medical device development experience. It provides regulatory strategy, QMS and technical documentation support, FDA submission support, and post-market support, and is an FDA-accredited Third Party Review Organization for 510(k) reviews.

cybersecurity risk managementDe Novo submissionsDesign History File developmentEU MDR/IVDR technical documentationFDA 510(k) submissionsFDA-accredited third party 510(k) reviewPMA submissionspost-market surveillanceQMS implementationregulatory strategytechnical documentation audits

Compiled from public sources

BIOREP TECHNOLOGIES, INC.

MIAMI LAKES, FL

Biorep Technologies, Inc. is a medical device CDMO based in Miami Lakes, FL, offering contract design and manufacturing of medical devices for over 30 years. ISO 13485 certified and FDA-registered, it provides prototyping, contract manufacturing, and assembly services from concept through scale-up and launch.

automated and manual assemblyChange Controlcleanroom assemblydesign for manufacturability (DFM) reviewfunctional and environmental testingin-process inspectionmulti-component assembly (mechanical, micro-mechanical, electromechanical)rapid prototypingsupply chain sourcingtolerancing

Compiled from public sources

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