As per WHO “Medical Devices” are defined as “any article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose.”
Expertise
Medical Device Classification
Good Manufacturing Practice (GMP) Compliance & Remediation Services
Compilation of documents and Submission
CE Technical File or Design Dossier Compilation for Medical Devices
CE marking for Medical Devices and In-Vitro Diagnostic (IVD) devices
Regulatory assistance in Pre-Market Approval of Application (PMA), Premarket Notification 510 (k), De novo Submission, Submitting 513(g) Submission
Establishment Registration for manufacturers, repackages, distributors and re-labelers
Listing of Medical Device with FDA
Labeling of medical devices in accordance with regulatory requirements.
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
About Us
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.