Case Studies

01
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DSIR Certification for a Regenerative Medicine

An Indian company specializing in regenerative medicine and therapy sought the prestigious DSIR (Department of Scientific and Industrial Research) ...

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02
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EOU Registration for MSME Medical Device Company

An MSME medical device company sought to establish a 100% Export Oriented Unit (EOU) in India. The company aimed to import, assemble...

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03
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ISO 27001 Implementation for SaMD Company

A Software as a Medical Device (SaMD) company developing healthcare applications and web portals required ISO 27001 certification to ensure ...

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04
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Metrology Compliance for Electronic Weighing Scale

A Taiwan-based manufacturer producing electronic weighing scales sought to obtain a Legal Metrology license in India. Compliance...

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05
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NPPA Compliance for Surgical Dressing Company

A surgical dressing company faced non-compliance issues with the National Pharmaceutical Pricing Authority (NPPA) regulations due to...

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06
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PCPNDT & AERB Compliance for Ultrasound & X-Ray

A medical device manufacturer producing ultrasound and X-Ray machines sought assistance in obtaining compliance with the PCPNDT Act for...

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07
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Regulatory Setup for Refurbished Medical Devices

A Mumbai-based company sought to establish a process for importing and refurbishing medical devices such as CT Scans, MRIs, Ultrasound machines...

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08
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STPI Registration for an IT and Digital Health Company

A Bangalore-based IT and digital health company exporting software services through cloud platforms like AWS and Microsoft Azure needed ....

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09
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510(k) Submission for ECG Interpretation Software (SaMD)

A client approached D2R Global Consulting with their ECG analysis and interpretation software, a Class II SaMD...

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10
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CDSCO Import License for Urethra Catheter

A healthcare company specializing in innovative medical devices sought to import its Urethra Catheter, designed to minimize iatrogenic...

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11
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CDSCO MFG License for Neonatal Baby Warmer

Chennai-based medical device company sought a CDSCO manufacturing license for their newly developed Baby Warmer (CIC 101). The device, designed as a...

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12
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CE Certification for Surgical Dressing product

The Indian branch of a MNC medical device manufacturer sought CE certification for Hemostat, a sterile absorbable gelatin sponge, to meet European regulatory...

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13
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Device Testing for Portable Fetal Doppler Device

An established Indian manufacturer of medical equipment approached D2R Global Consulting to conduct comprehensive testing of their portable fetal...

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14
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ABDM Integration for Radiological Imaging Product

Our client, specializing in radiological imaging, aimed to integrate their existing IT system with the Ayushman Bharat Digital Mission (ABDM) for...

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15
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Sterile IVD Manufacturing Facility Development.

Our client, specializing in personalized cancer diagnostics, engaged D2R Global Consulting to design and develop a 30,000 sq. ft. ISO...

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16
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India Market Entry for Surgical Dressing Company

A Canada based medical device company approached D2R Global Consulting seeking to enter the Indian market. Navigating...

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17
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Regulatory Approval for SaMD

An Indian healthcare technology start-up developed a diagnostic Software as a Medical Device (SaMD) for wound care...

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18
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Clinical Study for IVD Semen Detection Kit

An Indian start-up developed its first in vitro diagnostic (IVD) semen detection kit and needed validation of its...

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19
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MDSAP Certification for an Indian Electro-Medical Device MFG

An Indian medical device manufacturer specializing in electro-medical equipment aimed to achieve MDSAP (Medical Device Single...

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20
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Device Prototyping a Multiparametric Point-of-Care IVD Device

An Indian start-up partnered with D2R Global Consulting to design and develop a multiparametric point-of-care device capable...

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