Capability

PMA submissions

Suppliers: 1
States & provinces: 1
Countries: 1

1 pma submissions supplier across 1 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 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.

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

Related capabilities

Other processes offered by the shops that list PMA submissions.

CAPA management (1)
cybersecurity risk management (1)
De Novo submissions (1)
Design History File development (1)
EU MDR/IVDR technical documentation (1)
FDA 510(k) submissions (1)
FDA-accredited third party 510(k) review (1)
post-market surveillance (1)
QMS implementation (1)
regulatory strategy (1)
technical documentation audits (1)

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PMA submissions

Suppliers

BEANSTOCK VENTURES

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