A medical device manufacturer’s quality management system (QMS) is the foundation for maintaining Regulatory compliance, driving improvement, effectiveness and achieving stakeholder confidence in the manufacturer and their products.
Expertise
Medical Device Companies Audit as per ISO 13485
Medical Device Manufacturers Consulting and Implementation as per ISO 13485
Consulting and gap analysis as per ISO 13485:2016
QMS Compliance for Startup Medical Device Companies
Advantages
Cost-effective
End-to-end Regulatory consultation
Qualified team of experts with hands-on experience across all categories of personal care and cosmetic products like Skincare, Oralcare, Hair care, Baby care and beauty products.
Expert support for region-specific Regulatory complexities
Interactions with Health Authorities (HAs)
Structured approach to ensure quick product launch or market access