C-117, 3rd Floor,
Mayapuri Industrial Area Phase II,
New Delhi - 110064, India
Monday to Saturday
Landline: +91-11-4909 2567
E-mail: info@indosurgicals.com
IndoSurgicals Private Limited is committed to manufacturing and supplying safe, effective, reliable and cost-conscious medical devices through controlled processes, documented quality systems and applicable statutory and regulatory compliance.
Welcome to IndoSurgicals Private Limited, a trusted name in the medical equipment industry. As a manufacturer and supplier of medical devices, we place quality, safety, consistency and compliance at the centre of our operations.
Our certifications, approvals and licenses support our commitment to delivering products that meet applicable customer, statutory and regulatory requirements. These include ISO 9001, ISO 13485, CE Certification, GMP Certificate, CDSCO License, BARC Approval for radiation protection apparels, and Model Approvals for selected height and weight measurement devices such as Stadiometer and Infantometer from Legal Metrology, Ministry of Consumer Affairs, Government of India.
Every certificate or approval is linked with a defined scope. Customers are encouraged to review the certificate copy and product applicability for complete clarity.
Our quality approach is not limited to final inspection. It is built into supplier evaluation, raw material control, production monitoring, product verification, documentation and continuous improvement.
IndoSurgicals maintains multiple quality and regulatory credentials to support reliable medical device manufacturing, distribution and customer confidence.
ISO 9001 certification demonstrates our commitment to implementing and maintaining a structured quality management system focused on consistent products, customer satisfaction and continual improvement.
ISO 13485 is an internationally recognised quality management system standard for medical devices. It supports controlled design, development, production, storage, distribution and related activities within the certified scope.
CE certification indicates that applicable products covered under the certificate scope are assessed against relevant European safety, performance and conformity requirements.
Good Manufacturing Practices support consistent production, controlled processes, material traceability, hygiene discipline, documentation and quality assurance across manufacturing activities.
Our CDSCO medical device license supports applicable regulatory compliance for the manufacture and sale of covered medical devices in India, as per the license scope.
BARC approval for radiation protection apparels supports confidence in shielding performance for products intended to help protect healthcare professionals and patients from scattered ionizing radiation.
Selected height and weight measurement devices, including Stadiometer and Infantometer, have received Model Approvals from Legal Metrology under the Ministry of Consumer Affairs, Government of India.
We maintain quality records, inspection documentation, supplier controls and process records to support product traceability and consistent manufacturing output.
Feedback, audits, corrective actions, preventive actions and management review help us maintain and improve the effectiveness of our quality management system.
A simple overview of the major quality and regulatory credentials associated with IndoSurgicals Private Limited.
| Certification / Approval | Purpose | IndoSurgicals Focus |
|---|---|---|
| ISO 9001 Quality Management |
General quality management system standard. | Consistent processes, customer focus, documentation and continual improvement. |
| ISO 13485 Medical Devices |
Quality management system standard specifically for medical devices. | Controlled medical device manufacturing, risk-based thinking and regulatory discipline. |
| CE Certification European Conformity |
Conformity assessment for applicable products under the certificate scope. | Support for safety, performance and applicable European regulatory requirements. |
| GMP Certificate Manufacturing Practice |
Good Manufacturing Practices for consistent production. | Process control, hygiene discipline, traceability and quality assurance. |
| CDSCO License Indian Medical Device Regulation |
Regulatory license for covered medical device manufacturing activities in India. | Compliance with applicable Indian medical device regulatory requirements. |
| BARC Approval Radiation Protection |
Approval related to radiation protection apparels. | Shielding confidence for users working around diagnostic radiation environments. |
| Legal Metrology Model Approval Measurement Devices |
Approval for selected measuring devices such as Stadiometer and Infantometer. | Reliable and accurate measurement support for healthcare and clinical use. |
Our quality system is designed to reduce variation, improve reliability and support safe product use in healthcare environments.
Materials and suppliers are reviewed through defined quality requirements before use in production.
Manufacturing is carried out through documented processes, trained personnel and controlled conditions.
Products are checked against defined specifications to support performance, safety and consistency.
Documentation, feedback, audits and corrective actions help maintain and improve the quality system.
View key quality certificates, regulatory licenses and approvals associated with IndoSurgicals Private Limited.
Quality management system certification for consistent processes and customer-focused improvement.
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Medical device quality management certification supporting controlled manufacturing and regulatory discipline.
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Certification supporting conformity for applicable products covered under the CE certificate scope.
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Good Manufacturing Practices certificate supporting disciplined and consistent production processes.
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Medical device manufacturing license for applicable product categories covered under the license scope.
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Approval related to radiation protection apparels used for protection from scattered diagnostic radiation.
View CertificateCommon questions about IndoSurgicals quality certifications, regulatory approvals and product compliance.
Yes. IndoSurgicals holds ISO 13485 certification, which is a quality management system standard specifically designed for medical device organisations. Customers should refer to the certificate scope for covered activities and product categories.
ISO 9001 is a general quality management system standard, while ISO 13485 is focused on medical device quality management. ISO 13485 places stronger emphasis on regulatory compliance, product safety, risk control, documentation and medical device lifecycle requirements.
CE certification applies only to products and categories covered under the certificate scope. For exact applicability, customers should check the certificate copy or contact IndoSurgicals before placing an order.
CDSCO is India’s national regulatory authority for medical devices. A CDSCO license supports regulatory compliance for covered medical devices manufactured or sold in India, subject to the product category and license scope.
BARC approval supports confidence that the covered radiation protection apparels are evaluated for shielding performance. This is important for products used in radiology, X-ray, C-arm, diagnostic and other radiation-related healthcare environments.
IndoSurgicals Stadiometer and Infantometer have received Model Approvals from Legal Metrology under the Ministry of Consumer Affairs, Government of India. These approvals support reliable measurement use in healthcare and clinical settings.
At IndoSurgicals Private Limited, we take pride in our commitment to quality, compliance and customer satisfaction. Our certifications, approvals and licenses reflect our focus on safe, reliable and professionally manufactured medical equipment for hospitals, clinics, diagnostic centres, medical colleges and healthcare distributors.
