Overview
A medical device manufacturer’s quality management system (QMS) forms the foundation for Regulatory compliance, continuous improvement, effectiveness, and stakeholder confidence.
Expertise
- Medical Device Company Audits as per ISO 13485
- Consulting and Implementation for Medical Device Manufacturers per ISO 13485
- Gap Analysis and Remediation as per ISO 13485:2016
- QMS Compliance for Startup Medical Device Companies
Advantages
- Cost-effective
- End-to-end Regulatory consultation
- Qualified experts with hands-on experience across all categories of personal care, cosmetics, and medical devices
- Region-specific Regulatory support
- Interactions with Health Authorities (HAs)
- Structured approach for quick product launch or market access
