We facilitate our clients to obtain the following quality
certifications and accreditations
ISO 9001:2015- General QMS Certification
ISO 13485:2016 –Medical Devices & Diagnostics
Quality Management System Regulation (QMSR)
Medical Device Single Audit Program
(MDSAP)
FDA 21 CFR 820 Implementation
GLP – Good Laboratory Practices
GCP – Good Clinical Practices
GMP – Good Manufacturing Practices
ISO 27001:2022 – Information Security
ISO 15189:2022 – Medical
Laboratories
ISO 17025:2017 – Biological Testing of Laboratories
NABH Accreditation for Hospitals
CAP (College of American Pathologists) for
Diagnostic Labs
AABB (American Association of Blood Banks)
DUNS (Data Universal Numbering System)
Registration
DSIR (Department of Scientific & Industrial
Research) Registration
Established in 2018 (Previously Elite QARA Consulting), D2R is a turnkey medical device advisory services and solutions firm with access to global markets. Our team of 30 cross-functional domain experts specializes in Devices, Diagnostics, and Digital Health, enabling the business success of medical device manufacturers.
+1 (512) 761-0662
+91 63602 99044
info@d2rgc.com
No. 213, GF, Mallappa Layout, Babusapalya, Kalyan Nagar, Bengaluru, Karnataka, India - 560 043.