CDSCO & ISO India's Specialized Medtech CRO & Clinical Engineering Hub

Engineering Rigor.
Clinical Validation.
Regulatory Certainty.

A device tested only on the bench is not ready for a clinical site, and firmware instability invalidates trial data. OnlyWay Medtech integrates engineering rigor, hospital-based investigations, and structured regulatory preparation—supporting medical technology teams advancing innovations for India and preparing for strategic international market entry.

Schedule Scoping Call Explore Capabilities
50+
Hospital Trial Sites Across India
250+
Principal Investigators in Network
90 Days
Typical CDSCO Approval Time
ISO 14155
& ICH E6 Full Compliance
Biomedical engineering laboratory testing sensor array with digital telemetry waveform display
Firmware Freeze & V&V
Study-Ready Electronic Data Capture
Tier I & II Hospital Network
AIIMS, Tata Memorial, Max, Fortis
End-to-End Capabilities

Three Core Pillars.
Executed by One Unified Team.

Most medical device innovators fail not on scientific vision, but on the months it takes to get hospital approvals and engineering stability. We provide the complete multidisciplinary framework to take your device from prototype to certified clinical deployment.

PILLAR 01 • PRE-CLINICAL & HARDWARE RIGOR

Medtech & Engineering Support

The mission-critical work that has to happen before a device is fit to enter a clinical trial site, and the rigorous technical documentation demanded by regulators in domestic and international target markets. We work alongside your engineering and R&D teams to verify hardware performance, stabilize firmware, and structure technical files aligned with intended commercial jurisdictions.

“A device that has never been tested against a reference standard is not ready for a clinical site, and a study built on an unstable firmware build produces data nobody will accept.”
V&V Planning & Acceptance Criteria
Comprehensive claim-to-test matrices mapping intended performance claims directly to verifiable engineering parameters and quantitative acceptance limits suited for target-market technical files.
Controlled Bench & Reference Testing
Controlled laboratory comparisons against gold-standard hospital reference instruments and competing commercial devices under simulated physiological conditions.
Sensor & Algorithm Validation
Rigorous characterization of accuracy, drift, motion artifacts, latency, and edge cases, stress-testing algorithms before real patients wear them.
Study-Ready Data & Firmware Freeze
Secure timestamping, lossless data logging, automated export pipelines, and direct integration with Electronic Data Capture (EDC) systems.
Human Factors & Usability Engineering
Formative usability evaluations during design iterations and summative validation studies for CDSCO, US FDA, and CE Mark regulatory dossiers.
ISO 14971 Risk & Technical Files
Complete risk management files, hazard mitigation analyses, Design History Files (DHF), and essential principles documentation structured for international dossier harmonization.
Biomedical engineering bench test with digital oscilloscope, medical sensor board, and precision calipers
Clinical trial investigators reviewing medical device data in hospital research center
PILLAR 02 • HOSPITAL EVIDENCE GENERATION

Clinical Research & Validation

Evidence programmes tailored specifically for medical devices and wearables—where endpoints focus on performance agreement, diagnostic sensitivity, and usability across study designs planned to support evidence requirements in intended target markets.

ISO 14155 & ICH E6 Protocols: Designed jointly by clinical biostatisticians and medical scientists to generate GCP-compliant evidence recognized across multi-jurisdictional regulatory evaluations.
50+ Hospital Network: Immediate access to AIIMS Delhi, Tata Memorial, Safdarjung, Max, Fortis, Manipal, and Ruby Hall.
Pilot & Pivotal Execution: Institutional Ethics Committee (IEC) clearances, CTRI registration, patient enrollment, and real-time monitoring.
Real-World & Home-Use Studies: Ambulatory validation assessing wearability, battery compliance, and daily longitudinal physiological trends.
Clinical Data Management & ICH E3: Audit-trail database lock on Medidata Rave and LifeSphere, compliant biostatistical analysis, and ICH E3 study reports formatted for domestic and global dossier submissions.
Medical device QA regulatory lab showing ISO 13485 technical dossier and electrical safety testing rig
PILLAR 03 • STATUTORY CLEARANCES & QUALITY AUDITS

Regulatory & Certification Services

Navigating complex medical device statutory frameworks. We present CDSCO regulatory approval support for India alongside international quality systems and market-entry preparation as two specialized, distinct service tracks.

CDSCO Regulatory Approvals (India) 90-Day Avg.
Dedicated SUGAM & CTRI submission desks with standardized dossiers
Manufacturing & Import Licenses (Form MD-3, MD-5, MD-7, MD-9, MD-14, MD-15)
Subject Expert Committee (SEC) scientific defense and clinical trial permissions
Post-market surveillance (PMS) and materiovigilance reporting compliance
ISO Quality Systems & International Preparation QMS & Compliance
ISO 13485:2016 Medical Devices Quality Management System (QMS) implementation
ISO 14971:2019 Risk Management lifecycle planning and hazard documentation
IEC 62304 Medical Device Software Life Cycle & cybersecurity compliance
IEC 60601 Electrical Safety and essential performance test coordination
Technical documentation preparation and pathway planning for international markets, including US FDA 510(k)/PMA requirements, European Union Medical Device Regulation (EU MDR 2017/745) conformity dossiers, and Brazilian ANVISA regulatory submissions
Jurisdiction-specific regulatory gap analyses distinguishing Indian CDSCO rules from US, European, and Brazilian statutory frameworks
Methodology

The Path Most Device Companies
Take With Us

Stages can be contracted individually or as a complete turnkey program. We integrate intended target-market evidence and regulatory criteria early in the development lifecycle, providing one unified agreement, one dedicated project director, and one synchronized timeline.

01 2 - 3 Mos

Engineering Support

Hardware verification, sensor characterization against reference instruments, firmware freeze, and study-ready data architecture established.

02 2 Months

Protocol & Design

Device claims mapped to measurable, defensible clinical endpoints aligned with intended Indian and international launch expectations. ISO 14155 protocol, CRF, and statistical analysis plans drafted.

03 4 - 6 Mos

Pilot Execution

Institutional ethics committee approval, site activation in our hospital network, patient recruitment, and live adaptive trial monitoring.

04 Concurrent

Device Evaluation

Head-to-head accuracy, precision, formative/summative usability, and pragmatic real-world ambulatory performance data evaluated alongside Stage 3.

05 1 - 2 Mos

Evidence Package

Audit-locked database, ICH E3 clinical study report, peer-reviewed manuscript drafts, and technical dossiers structured for CDSCO submissions and international target-market compliance review.

Why a Medical Device Study is Not a Small Drug Trial

Device validation requires fundamentally different clinical mechanics, comparator controls, and statistical assumptions.

Dimension Traditional Drug Trial Device & Wearable Study (OnlyWay Medtech)
What is Tested A fixed chemical molecule at a fixed biochemical dose. Dynamic Product An evolving device with firmware updates, ergonomics, fit, and user interface.
Primary Endpoint Biochemical markers, pharmacokinetics, or mortality/morbidity. Performance Measurement accuracy, diagnostic agreement (Bland-Altman), symptom score, or patient behavior.
Comparator Placebo control or established standard-of-care pharmaceutical. Reference Benchmarks Calibrated hospital reference instrument, competing commercial device, or sham unit.
Blinding Feasibility Double-blinded pills or matched saline infusions usually achievable. Protocol Designed Rarely double-blindable; bias must be engineered out through automated data logging and objective analytics.
Data Source Scheduled hospital visits and periodic blood/tissue laboratory assays. Continuous Stream High-frequency sensor telemetry from the hardware itself, paired with digital Patient-Reported Outcomes (ePRO).
Governing Standards ICH E6 Good Clinical Practice and national pharmaceutical drug rules. Medtech Standards ISO 14155, ISO 14971, IEC 62304, and international Human Factors guidance.
Commonest Failure Mode The active chemical molecule fails to produce biological efficacy. Methodology Error The hardware works, but the clinical protocol was not designed to prove it to a hospital committee or regulator.
Operational Machinery

In-House Infrastructure &
Therapeutic Reach

From temperature-controlled device logistics to dedicated regulatory desks and specialized clinical software, our infrastructure handles the heavy lifting of clinical trials in India.

Dedicated SUGAM & CTRI Desk

In-house regulatory liaisons managing online filings, ethics committee queries, and regulatory committee hearings with CDSCO to compress approval lead times.

SUGAM Portal CTRI Registration SEC Representation Import License (MD-15)

Electronic Data Capture (EDC) & Audits

Fully validated clinical data management platforms compliant with 21 CFR Part 11, including Medidata Rave and LifeSphere, maintaining unalterable digital audit trails.

Medidata Rave LifeSphere EDC 21 CFR Part 11 Automated Query Resolution

Multidisciplinary Therapeutic Depth

Deep investigator relationships across cardiology, pulmonology, diabetes/metabolic health, oncology, digital wearables, and decentralized home monitoring studies.

Wearables & RPM Cardiology Respiratory Health Endocrinology Precision Oncology

50+ Active Hospital Trial Sites in India

Device sponsors rarely fail on engineering alone; they fail when hospitals take months to approve protocols. We operate direct investigator networks across India's most respected medical institutions.

AIIMS Delhi Tata Memorial Hospital Safdarjung Hospital Max Healthcare Fortis Healthcare Manipal Hospitals Ruby Hall Clinic
50+
Hospitals Across Tier I & Tier II Cities
250+
Principal Investigators in Active Network
90d
Average Regulatory Approval Speed
15+
Academic Medical Centers Collaborating
Who We Are

Bridging the Gap Between
Hardware Labs & Hospital Wards

OnlyWay Medtech Private Limited is a specialized contract research and medical engineering organization founded by clinical trial veterans. Having executed interventional studies to rigorous pharmaceutical standards across India, we recognized a systemic gap: medical device, wearable, and wellness technology innovators were struggling with clinical study designs that were built like drug trials.

We established OnlyWay Medtech to provide the specialized operational machinery devices demand: supporting the pre-clinical bench testing and firmware stabilization that must occur before recruitment, executing real-world hospital validation, and assisting teams with CDSCO licensing, ISO certifications, and technical dossier preparation for intended international markets—all under one unified contract.

One Contract & Timeline

No finger-pointing between independent engineering labs, clinical sites, and regulatory agents.

Pharmaceutical Discipline

ICH E6, ISO 14155, and ISO 14971 standards applied rigorously to every device trial.

REPRESENTATIVE ENGAGEMENT

Consumer Wellness Wearable: Respiratory Claim Defense

The Challenge: A fast-growing wearable company had substantial retail traction and a novel physiological claim regarding respiratory symptom tracking. However, they lacked defensible clinical data to satisfy hospital procurement committees, commercial insurance payers, and regulatory auditors.

The Solution: We aligned device sensor output to validated clinical respiratory scores, conducted pre-trial bench sensor calibration, activated a controlled hospital proof-of-concept pilot with real-time monitoring, and delivered a complete ICH E3 study report with a peer-reviewed manuscript draft.

Turnaround: 5 Months to Validated Dossier Discuss Similar Study →
Let's Discuss Your Device

Schedule a Technical Scoping Call

Send us your device specifications and the regulatory or clinical claim you need to defend. Our clinical engineering team will analyze the gaps and provide an actionable study design, realistic timeline, and indicative budget within 1 business day.

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Direct communication with our medical engineering and clinical operations directors.

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Registered Corporate Office

OnlyWay Medtech Private Limited
304, Third Floor, Deenar Bhawan, Nehru Place
New Delhi 110019, India

Direct Inquiries & Scoping

+91 9971234680
info@onlywaymedtech.in
sukriti.dugal@gmail.com

30-Minute Scoping Guarantee

A standard scoping call takes thirty minutes and concludes with a definitive perspective on trial feasibility, necessary pre-clinical bench tests, realistic hospital timelines, and indicative costings.