Launch, Certify and Grow
At Qualiin, we specialize in delivering actionable regulatory and quality compliance solutions for the life sciences sector. Whether you’re a medical device startup navigating CDSCO approvals or a manufacturer preparing for CE marking or US FDA clearance, we provide strategic, end-to-end guidance to keep your innovation compliant and market ready.
A passion for creating spaces
Our comprehensive suite of professional services caters to a diverse clientele, ranging from homeowners to commercial developers.
Regulatory Affairs & Market Access
• CDSCO, FDA (510k), CE Marking Submissions
• Technical File & Dossier Preparation
• Import Licensing, FSC, MSC, NCC
QMS Implementation & Audit Readiness
• ISO 13485, 9001, 27001 Compliance
• eQMS (Greenlight Guru, Qualio)
• Internal Audits, SOPs, and CAPA Programs
Facility Setup & Validation
• ISO Class 5–8 Cleanroom Design
• Turnkey Layouts: CE, WHO-GMP, CDSCO
• Equipment Qualification & Process Validation
Product Development & Clinical Compliance
• Clinical Evaluation Reports (CER)
• Biocompatibility Test Strategy
• Labeling, IFU, and Packaging Development
Supply Chain & Manufacturing
• BOM Vendor Sourcing
• Sterile & Non Sterile Injection Moulding
• Tooling, Procurement, Process Validation
Our Medical Device Development & Compliance
• Precision 3D prototyping for medium-scale devices
• Secure, high-performance firmware
• Flawless hardware–software integration
WHY CHOOSE QUALIIN?
We deliver end-to-end medical device regulatory support with deep domain expertise and strong systems built for real-world success.
Full-Spectrum Regulatory Services
- Licensing to Post-Approval: We manage everything from initial approvals to market surveillance.
- Facility & Cleanroom Setup: Guidance through infrastructure readiness and validation.
- Ongoing Compliance: Continued support to stay audit-ready and compliant.
Expertise with Business Alignment
- Domain-Focused Teams: Specialists in diagnostics, implants, and sterile products.
- Business-Integrated Strategy: Speed-to-market with risk and cost in balance.
- System-Driven Execution: SOPs, trackers, and eQMS ensure reliable delivery.
