Global Regulatory &
Commercialization Services
EquipSecond helps innovative medical technology companies navigate regulatory approvals, clinical validation, business setup, and commercialization across India and the United States.
ORTIV by MVITRO
EquipSecond serves as MVITRO’s strategic partner for regulatory coordination, clinical validation, and commercialization support across India and the United States.
ORTIV by MVITRO
EquipSecond serves as MVITRO’s strategic partner for regulatory coordination, clinical validation, and commercialization support across India and the United States.
India Regulatory Representation
EquipSecond India acts as regulatory agent and has supported CDSCO clearance for test and demonstration activities, helping prepare the product for clinical and commercial pathways in India.
US Business Establishment
EquipSecond USA supported MVITRO, a South Korea–based medical device company, in establishing Aponex Inc., its wholly owned U.S. subsidiary, to support business operations, regulatory activities, and future commercialization across the United States.
FDA Readiness & Regulatory Strategy
We help international med-tech companies prepare documentation, validation strategy, clinical evidence plans, and regulatory pathways for US market entry.
Neonatal Commercialization Support
With strong neonatal and critical care roots, EquipSecond helps partners introduce innovative technologies into NICU and hospital networks.
Korea-to-US/India Market Access
Our long-term goal is to support more Korean medical technology companies with regulatory strategy, local representation, commercialization, and market access in India and the United States.