BusinessWire India
Bangalore (Karnataka) [India], October 14: Reghelps SRC, a newly established Contract Research Organization (CRO) in India, announced the launch of its comprehensive clinical research services for global Medical Device and In-Vitro Diagnostic Device (IVD) manufacturers.
With India emerging as a globally preferred destination for clinical research, Reghelps SRC is committed to accelerating clinical investigations and performance evaluation studies for manufacturers seeking compliance under EU MDR 2017/745, IVDR 2017/746, US FDA, and Indian CDSCO regulatory frameworks.
With over two decades of combined leadership experience in regulatory affairs, clinical strategy, and medical device research, Reghelps SRC brings together expert clinicians, biostatisticians, and regulatory specialists to deliver high quality, evidence-based outcomes for global regulatory submissions.
Bridging Clinical Research and Regulatory Compliance
Reghelps SRC provides end-to-end clinical study management in India, including protocol design, site selection, ethics committee approvals, patient recruitment, data management, and final clinical report preparation.
The team of experienced clinical research professionals, investigators, and data analysts ensures that all studies strictly adhere to global standards.
"Our mission is to help global medical device and IVD manufacturers conduct reliable, regulatory-compliant studies in India with faster turnaround times and superior data integrity," said Mr. Soio George, Founder and CEO at Reghelps SRC. "By combining deep regulatory knowledge with hands-on research experience, we bring efficiency and trust to every stage of clinical investigation and performance evaluation."
Clinical Research Services for Medical Devices
* Clinical Investigation Studies: Pilot, pivotal, and post-market studies compliant with EU MDR 2017/745 and ISO 14155.
* Post-Market Clinical Follow-up (PMCF): Real-world clinical data collection to maintain CE certification and optimize device performance.
* Usability Engineering: Human factors validation and usability assessments to ensure safe and effective device use.
Performance Evaluation and Research for IVD Devices
* Analytical Performance Evaluation: Validation of precision, accuracy, sensitivity, specificity, and detection limits of IVD assays.
* Clinical Performance Evaluation: Execution of studies to demonstrate clinical validity in real-world healthcare settings.
* Post-Market Performance Follow-up (PMPF): Continuous monitoring to ensure IVDR 2017/746 compliance.
Regulatory and Statistical Support
Regulatory and Statistical Support services include Clinical Evaluation Plans (CEP), Clinical Investigation Plans (CIP), Statistical Analysis Plans (SAP), and Comprehensive Study Reports and Summary Documentation. Each document is prepared to meet international regulatory standards, ensuring robust clinical evidence for CE Marking, IVDR, FDA, and other global submissions.
These services are designed to assist medical device startups, established manufacturers, and global regulatory consultants in India and abroad. By partnering with Reghelps SRC, manufacturers gain a reliable CRO partner for clinical investigations, PMCF studies, and IVD performance evaluation services, enabling faster, compliant, and high-quality regulatory submissions.
Driving Clinical Research Excellence in India
With advanced data collection tools, dedicated clinical project managers, and an established network of hospitals and laboratories, Reghelps SRC ensures efficient project execution with full regulatory transparency. In collaboration with I3CGLOBAL, the company provides a seamless connection between clinical research execution and regulatory documentation, supporting submissions for CE Marking, UKCA, TGA, CDSCO, and FDA approvals.
"Together with I3CGLOBAL, we aim to make India a strong hub for medical device and IVD research," added by Mr. NagaChandra Bhardwaj, Co-founder and CTO. "Our goal is to provide reliable, ethical, and scientifically valid study outcomes that help manufacturers achieve regulatory compliance."
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