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EU MDR and US FDA Quality Assurance and Regulatory Support Worldwide.

Anytime, Anywhere !!!


makes QARA the best choice for Quality Assurance and Regulatory affairs personnel looking for external support.

The Unique cloud based documentation and long distance video meeting saves lot of time money and incidental expenses. The Quality of consultants and their technical knowledge can be measured during the first meeting itself, which increases the clients confidence.


Our Services

CE Marking
Medical Device CE Marking

CE Marking of Medical Device approval guidance and documentation service online is fast and cost effective.

21 CFR 820
US FDA 21 CFR 820

Check out our online service advantages and process of implementing GMP and closing FDA 483's.

US-FDA 510 K
FDA 510(k)

You need a qualified consultant throughout the 510k preparation and during the FDA review process

ISO 13485
ISO 13485 Certification

Our Online service is designed to benefit clients in implementing medical device quality management system

US FDA Registration & Listings
US FDA Registration Consultants

Our around the clock service is helpful for customers interested to register with FDA from any country or any time zone


Our exclusive feature of preparing the Drug Master File Oline to complete the process fast and error free

Technical File Guidance

LiveZilla Live Chat Software