Medical Device Regulatory & Quality Consulting Services

Regulatory strategy, submission support and licensing across global markets.

Global regulatory pathways, FDA 21 CFR Part 4, EU MDR Article 117 Notified Body Opinions (NBOp), DHF and ISO 14971 compliance.

Decision-grade regulatory audits for M&A, private equity investments, QMS maturity, FDA 483 assessments, and valuation risk modeling.

CDSCO COS-1/COS-2 import registration, US FDA MoCRA compliance, EU/UK Responsible Person (RP), CPSR, and international notifications.

Registration Certificate (Form 41), Import License (Form 10/10-A), Form 11 Test Licenses and wholesale distribution support.

Equipment Type Approval (ETA), Dealer Possession Licenses (DPL) and RF test compliance for connected devices.

Statutory Form A & Form B registration for ultrasound, imaging machines and diagnostic equipment in India.

Import Export Code (IEC) and Authorised Dealer (AD) Code registration across Indian customs ports.

ISO 13485, QMS development, internal audits, CAPA & compliance readiness.

Prepare your Quality Management System for global MDSAP audits.

End-to-end technical file writing (STED), risk management & compliance support.

Market entry strategy, pricing, reimbursement & post-market compliance.

cGMP-compliant pharmaceutical machinery, SS 304/316 cleanroom furniture, blenders, conveyors, and material handling solutions.

Internal audits, supplier audits, compliance & regulatory intelligence.