Regulatory & Compliance
Transparency on regulatory status is not optional for a medical product
This page documents ScanOFe's current regulatory position, certification status, intended use statement, and data privacy approach. We publish this information because clinicians and institutions deserve to know exactly where a clinical tool stands before they use it.
Intended Use Statement
What ScanOFe is. And is not. Intended to do
The intended use statement is the regulatory foundation of any clinical decision support tool. It defines the product's scope, its user population, and the boundaries of its clinical function.
Formal Intended Use Statement
ScanOFe is an AI-assisted clinical decision support software intended for use by qualified healthcare professionals. Specifically fetal medicine specialists, obstetricians, and radiologists performing prenatal ultrasound. To assist in the interpretation of abnormal fetal ultrasound findings. ScanOFe provides structured clinical reasoning support by linking clinician-entered ultrasound findings to possible fetal malformations, associated syndromes, causative genes, and recommended targeted investigations. ScanOFe operates exclusively on clinician-entered data and does not analyse, process, or re-interpret ultrasound images.
ScanOFe is not intended to: generate independent diagnoses, replace the clinical judgment of a qualified healthcare professional, replace formal genetics consultation on complex cases, direct clinical management or treatment, or be used as a screening tool in an unqualified clinical setting.
ScanOFe is intended to: support clinical decision-making after abnormalities have been identified by a qualified clinician, reduce cognitive load associated with syndrome and gene identification, structure the documentation of clinical reasoning, and support targeted investigation selection.
User population: Fetal medicine specialists, obstetricians with advanced ultrasound practice, radiologists performing prenatal ultrasound, genetic counselors, and trainees under qualified supervision.
Current Regulatory Status
A complete picture of where we stand
The table below reflects ScanOFe's regulatory status as of the date of this page's last update. We update this information when status changes.
| Jurisdiction | Regulatory Body / Framework | Classification | Status | Notes |
|---|---|---|---|---|
| India | CDSCO. Central Drugs Standard Control Organisation Medical Devices Rules, 2017 |
Class A. Low Risk Medical Device | Filing in Preparation | Regulatory documentation being compiled. Class A classification based on decision support software categorisation. Current access limited to supervised pilot programs. |
| European Union | CE Mark in Progress. EU Medical Device Regulation EU MDR 2017/745 |
Class I. Low Risk Medical Device Software | Planned | CE Mark in Progress application under EU MDR planned following CDSCO approval. Technical file skeleton prepared. Clinical evaluation plan in development. |
| ISO Quality | ISO 13485:2016 Medical Devices QMS |
Quality Management System | Active. Cert. No. 25101703 | Issued 17 October 2025. Surveillance audit due 16 October 2026. Recertification due 16 October 2028. Issued by A-Mark Ratings Limited (UKAS/IAF accredited). |
| India | DPIIT. Startup India Startup Recognition |
Healthcare & Lifesciences | Active. DIPP161287 | Recognised as a startup by Department for Promotion of Industry and Internal Trade. Valid through 16 February 2034. |
ISO 13485:2016
Quality management. What it means in practice
ISO 13485 is the international standard for quality management systems specific to medical devices. It covers not only product quality but the processes by which medical device software is designed, developed, tested, documented, deployed, and supported.
Certified Scope: Design, Development, Installation & Commissioning, and After-Sales Support of a Decision Support Tool Software for Obstetricians and Gynecologists.
ISO 13485 certification means GrowthGuardian maintains documented processes for requirements management, software development, risk management (aligned to ISO 14971), validation and verification testing, incident management, and post-market surveillance. It does not certify that a product is approved for clinical use. That is the function of CDSCO and CE Mark in Progress approval.
The certificate is subject to annual surveillance audits. Suspension or cancellation would occur if the surveillance audit is not completed on schedule. Full certificate documentation is available on request.
Certificate Number
25101703
Certification Body
A-Mark Ratings Limited
Stockport, England. IAF MLA Accredited
Date of Initial Registration
17 October 2025
Surveillance Audit Due
16 October 2026
Recertification Due
16 October 2028
Certificate Holder
GrowthGuardian Pvt Ltd
B-601, Surya Emerald, Ambli, Daskroi
Ahmedabad. 380058, Gujarat, India
Product Classification
ScanOFe as a Clinical Decision Support Tool
ScanOFe is classified as a Clinical Decision Support Tool (DST). Not a diagnostic AI, not an imaging device, and not a standalone medical device that generates clinical decisions. This classification has specific implications for how the product functions, how it is regulated, and how clinical responsibility is allocated.
✅ What DST classification means
A Decision Support Tool supports qualified clinicians in making clinical decisions. It does not make those decisions independently. The clinician retains full diagnostic and treatment authority. ScanOFe's outputs are recommendations and structured information, not diagnostic conclusions. The clinician must apply their own judgment to all ScanOFe outputs.
🔍 How ScanOFe differs from diagnostic AI
Diagnostic AI tools (such as image analysis software) process clinical inputs and generate autonomous diagnostic conclusions. ScanOFe does not process images, does not generate diagnoses, and does not operate independently of clinical input. Every output is contingent on clinician-entered data and must be reviewed by the clinician before any clinical action.
⚖️ Clinical responsibility
The use of ScanOFe does not transfer clinical responsibility from the clinician to GrowthGuardian or to the software. The clinician using ScanOFe remains professionally and legally responsible for all clinical decisions made in the care of their patients. ScanOFe is a tool to assist that decision-making, not to automate it.
🏥 Appropriate clinical settings
ScanOFe is intended for use in settings where qualified fetal medicine specialists, obstetricians, or radiologists are conducting prenatal ultrasound assessment. It is not appropriate for use in unsupervised screening settings, by unqualified operators, or as a substitute for fetal medicine specialist consultation on complex cases.
CE Mark in Progress Roadmap
Our path to EU MDR compliance
CE Mark in Progress under EU MDR 2017/745 is a planned regulatory milestone for ScanOFe. The following outlines the key stages of the CE Mark in Progress pathway. The sequence is contingent on CDSCO approval being obtained first, which provides the clinical evidence foundation required for EU MDR Clinical Evaluation.
ISO 13485:2016 Certification
Quality management system certification in place. Forms the backbone of the technical file and demonstrates process compliance required for EU MDR.
Technical File Skeleton
CE/MDR technical file structure prepared, including device description, classification justification, software lifecycle documentation, risk management framework, and labelling requirements.
CDSCO Class A Registration (India)
Primary regulatory approval target. Regulatory documentation compilation in progress. CDSCO approval provides the clinical evidence base used to support the EU MDR Clinical Evaluation Report.
Prospective Clinical Validation
Multicenter validation study with academic fetal medicine centres. Required for EU MDR Clinical Evaluation. Planned in parallel with CDSCO submission period.
Clinical Evaluation Report (CER)
Formal Clinical Evaluation Report per EU MDR Annex XIV, incorporating retrospective validation data and prospective study outcomes. To be completed by an independent clinical evaluator.
CE Mark in Progress Application & Self-Declaration (Class I)
CE Mark in Progress self-declaration under EU MDR for Class I software medical device. Includes technical file submission, conformity declaration, and EU representative appointment.
Data Privacy
How ScanOFe handles clinical data
ScanOFe's data privacy approach is built around a core design principle: clinical decision support does not require patient-identifiable data. The platform is architected to deliver its function without the collection or storage of personally identifiable health information.
🔒 No patient identity required
ScanOFe generates its clinical outputs from findings data alone. Gestational age, measurements, structural anomalies. Patient names, dates of birth, record numbers, and other identifiers are not required for any core function and are not requested by the platform.
🏛️ Institutional data tenancy
Institutional deployments operate under separate data tenancies. No clinical data entered by one institution is accessible to any other institution or to the ScanOFe team without explicit consent and a formal data access agreement.
🔐 Encryption standards
All data in transit is encrypted using TLS 1.3. All data at rest is encrypted using AES-256. Security architecture documentation is available to institutional IT teams on request under NDA.
📋 DISHA alignment
Data handling aligned to the Digital Information Security in Healthcare Act (DISHA) framework applicable to health data in India. GDPR-aligned data handling protocols in place for CE-market deployments.
📄 Data Processing Agreement
A formal Data Processing Agreement (DPA) is available for all institutional customers. The DPA defines data controller/processor relationships, data retention periods, breach notification procedures, and subject access rights.
🔍 Audit and transparency
Administrator accounts include audit log access. GrowthGuardian does not use clinical data entered through ScanOFe for training purposes without explicit, written institutional consent under a separate research agreement.
Full Regulatory Disclosure
ScanOFe is a clinical decision support software product developed by GrowthGuardian Private Limited. It is not currently approved by CDSCO for commercial sale in India. It does not hold a CE Mark in Progress under EU MDR. Current access to ScanOFe is provided exclusively through structured pilot and evaluation programs, under the supervision of qualified fetal medicine specialists or radiologists.
ISO 13485:2016 certification (Certificate No. 25101703, issued 17 October 2025) covers the quality management system for the design, development, installation, commissioning, and after-sales support of the software. This certification is not equivalent to, and does not substitute for, regulatory approval to market or commercially distribute a medical device.
ScanOFe is a Clinical Decision Support Tool. All clinical outputs generated by ScanOFe are advisory in nature and must be reviewed and interpreted by a qualified healthcare professional. ScanOFe does not replace clinical judgment, does not generate independent diagnoses, and does not direct clinical management or treatment. GrowthGuardian Private Limited accepts no clinical liability for decisions made on the basis of ScanOFe outputs.
This page reflects regulatory status as at the date of last update. For questions regarding regulatory documentation, compliance inquiries, or data processing agreements, contact: tapan@scanofe.com
Questions about regulatory status or compliance documentation?
We respond to compliance inquiries from clinical and institutional decision makers. Contact us directly or request a compliance documentation package.