MDTL Medical Device Incubator Service
MDTL medical device incubator services offer comprehensive support for medical device development, including facility utilization, quality management guidance as per National and international regulation requirement (e.g. ISO 9001,ISO 13485,ISO 14001, ISO 45001, MDSAP,ICMED 13485, IMDR, UK MDR, EU MDR QMS, EU IVDR QMS, 21 CFR Part 820 etc), IMDR (MDR 2017) Implementation, Licence & Permission from CDSCO, CE Marking (Medical Device, PPE, Machinery, LVD), USFDA Establishment, Listing, 510k Submission, Export Product Registrations (AFRICAN COUNTRIES,GULF / MIDDLE EAST COUNTRIES, ASIAN COUNTRIES, RUSSIA / CIS), Technical Document Writing (Registration Dossier, Technical Files(EU), Medical Device File, Risk Assessment, CER, PMS, PMCF, PSUR, DHF), UDI Implementation Guidance, EU REP,UK REP, US Agent, Indian Authorized Agent, Internal Audit, Supplier Audit Service, Third-party Inspections & Trainings, clinical and R&D builds, full traceability, and product conformity and validation support.
Medical Devices innovators and entrepreneurs can benefit from these Government Schemes for Funding and Financing Medical Devices in India.
Schemes for Medical Devices Manufacturing | Invest India
