Call Us for any Regulatory Support (ectd, fda, EU, MHRA regulatory authorities): +919998661845
Medical Device Registration Services
Medical Device Registration
Medical Device manufacturers takes all the steps necessary to ensure product quality but different regulations, across all the global regulatory are the major concerns for a Medical Device Companies and Managing every product, operation, and resource of a business is difficult in current time
We the NR PharmReg Team ensures stringent regulatory compliances for medical device manufacturers. The company offers precise documentation and complete traceability of every product, operation, and resource.
We helps Medical Device companies in Preparation, Publishing and submission o regulatory applications:
- CDSCO submission
- US - FDA 510(k) submissions
- US - FDA Pre-Submission Applications
- US FDA Establishment Registration(ER and FEI) for Device Companies, Manufacturer and Applicant
- Europe - Technical files - CE submission
- Health Canada submissions
- Israel - AMAR submissions
- Malaysia submission
- Bangladesh submission