Medical Device Trials
Specialized Device & Biotech Studies Across India
eteraflex connects delivers medical device trials and biotech clinical evaluations from feasibility assessment to pivotal studies. With Class I–III device expertise, accelerated regulatory pathways, and a nationwide network of premier institutions, we support rapid and compliant product development.
Medical Device and Biotech Clinical Evaluation
eteraflex connects specializes in medical device studies and biotechnology clinical programs, supporting complete lifecycle development from early feasibility to pivotal clinical trials.
Our trials cover Class I, II, III devices and advanced biotechnology programs including cell therapy, gene therapy, biosimilars, and rare disease treatments.
Our Medical Device & Biotech Trial Capabilities
Class I–III Device Programs & Advanced Biotech Development
Our India-based clinical programs deliver full-cycle device and biotech development support through:
Safety Monitoring & AE Management
Class I–III device studies, implantable technologies, diagnostic systems, digital health (SaMD), and IVD diagnostic accuracy/validation.
Biotechnology Clinical Programs
Advanced therapy medicinal products (ATMPs), gene/cell therapy evaluations, companion diagnostics, biosimilars, and orphan drug research.
Regulatory Excellence for Devices
6–8 week accelerated manufacturing licenses, CER/PMCF support, regulatory pathway optimization, and complete documentation compliance.
Regulatory Submission Support
Pre-submission consulting, India-specific protocol design, CDSCO dossier preparation, query response management, and post-approval maintenance.
Our services span feasibility, pilot, pivotal, and post-market device and biotech studies with full regulatory and operational support.
How We Deliver
eteraflex ensures seamless device and biotech trial execution through a structured and fully compliant operational framework:
- Specialized Device Study Management: End-to-end oversight of device-specific processes, risk assessment, and technical documentation.
- Accelerated Regulatory Pathways: Achieve manufacturing licenses in 6–8 weeks—significantly faster than the industry average.
- Biotech Study Operations: Precision enrollment, biomarker-driven workflows, and ATMP-specific procedures.
- Device-Specific Monitoring: Risk-based monitoring aligned with ISO 14155 & ICH-GCP requirements.
- Regulatory Coordination: Complete CER, PMCF, dossier development, and regulatory correspondence.
Our integrated approach delivers consistent quality, faster approvals, and full compliance across global device and biotech programs.
Technology & Quality
ClinitraiX Device & Biotech Platform — Built for Compliance & Speed
eteraflex connects leverages ClinitraiX to streamline device risk assessment, biotech data management, and regulatory documentation.
Technology Platform Integration
- Optimized workflows for device and biotech study documentation
- Real-time visibility into regulatory progress
Centralized compliance database with audit-ready structure - Faster decision-making with analytics for device performance data
- Standardized templates for CER, PMCF, and biotech evaluation reports
Quality & Compliance Excellence
- ISO 14155 and ICH-GCP aligned processes
- Device-focused risk-based monitoring methodologies
- Independent quality oversight with full audit trail systems
- Inspection readiness for CDSCO, FDA, EMA
- Continuous compliance tracking throughout study conduct
A Trusted Clinical Network for Device & Biotech Trials Across India
Our research network spans Tier-1 hospitals, government medical colleges, and specialized biotech centers, enabling high-quality device validations and advanced therapeutic studies.
Premier Medical Institutions
Government colleges, corporate hospitals, and advanced diagnostic environments supporting high-standard device evaluations.
Specialized Device & Biotech Facilities
Research units equipped for implantable devices, gene/cell therapy handling, biomarker labs, and digital health assessments.
Standardized Quality Framework
Uniform ISO 14155–aligned procedures, regulatory documentation systems, and consistent quality standards across institutions.
