Quality Assurance and Regulatory Compliance
We offer complete product lifecycle management, including quality systems for Medical Device OEMs and startups. Services cover regulatory compliance, product safety standards, and international registrations. Certified to ISO 13485 and UL for Wiring Harness Assembly, we ensure top quality in healthcare and manufacturing.
Key Offering
- USA – Product 510(k) File Building and submission support.
- Other World Countries product registrations in regions like MEA, SEA, and LATAM.
- ISO 13485 Quality Management Systems establishment.
- India MDR - CDSCO Manufacturing License, Import License, Distribution Licence.
- EU MDR – CE Certification associated Technical File building support.