Streamlined Compliance and Market Authorization
At Indivirtus Healthcare Services Pvt. Ltd., our Medical Device Regulatory Support services provide end-to-end solutions for device classification, dossier preparation, and clinical evaluation across India, US, and EU markets. We ensure full compliance with CDSCO, EU MDR, and FDA requirements, including Indian Authorized Agent services for seamless market entry.
Our services include device classification (Class A–D), TDF/CSDT dossier preparation, clinical evaluation reports (CER), Risk Management Files (RMF), and Indian Authorized Agent support, ensuring compliance with global standards.
Accurate classification and compliant dossiers ensure regulatory approval, minimize delays, and facilitate market entry for medical devices across global jurisdictions.
As a trusted CRO, Indivirtus Healthcare Services delivers expert-led regulatory solutions, providing tailored support for medical device filings and market authorization.
At Indivirtus Healthcare Services, our Medical Device Regulatory Support services are led by certified regulatory experts with global compliance expertise. We determine accurate device classifications, prepare TDF/CSDT dossiers, compile CERs and RMFs, and provide Indian Authorized Agent services for CDSCO registration.
Our structured approach ensures submission-ready documentation, aligning with CDSCO MDR 2017, EU MDR 2017/745, US FDA 21 CFR Part 807, and other global standards to support seamless market entry.
Device Classification Assessment Report: Accurate classification for regulatory compliance.
TDF/CSDT Dossier Preparation: Region-specific, submission-ready dossiers.
Clinical Evaluation Report (CER): Comprehensive clinical data evaluations.
Risk Management File (RMF): Detailed risk assessment documentation.
Authorized Agent Representation Documents: Support for CDSCO registration in India.
Our Medical Device Regulatory Support services align with stringent global standards, ensuring your submissions are audit-ready and compliant with international markets. By adhering to industry-leading guidelines, we deliver solutions that enhance regulatory confidence and approval success.
Our Medical Device Regulatory Support services are essential for manufacturers targeting global market authorization. Ideal for new device filings, clinical evaluations, and CDSCO registration, our solutions support compliance and market access. Key use cases include classifying Class A–D devices, preparing dossiers for FDA/EMA, and acting as an Indian Authorized Agent for foreign manufacturers.
Indivirtus Healthcare Services is a trusted partner for medical device manufacturers, delivering expert-led regulatory solutions backed by certified professionals with global experience. Our services ensure scientifically defensible outcomes, rapid delivery, and strict confidentiality to protect your proprietary information.
With a commitment to industry best practices, we empower your organization with compliant, efficient regulatory processes, driving approval success and market readiness.
Our regulatory team assesses your device's intended use, risk level, and design specifications to determine the appropriate class under CDSCO, EU MDR, or FDA guidelines.
TDF (Technical Documentation Format) is used for India-specific filings (CDSCO), while CSDT is a global template especially used in ASEAN regions. Both formats include safety, performance, and risk data.
A CER provides evidence that your medical device is safe and performs as intended, based on clinical data. It is mandatory under EU MDR and often expected by other regulators.
The RMF is a key part of your device dossier that outlines identified risks, control measures, and benefit-risk analyses, usually developed according to ISO 14971.
The agent acts as your local representative in India for communication with CDSCO, submission of documents, and handling of regulatory obligations on your behalf.
Our services include device classification, TDF/CSDT dossier preparation, Clinical Evaluation Reports (CER), Risk Management Files (RMF), and Indian Authorized Agent support.
Medical device manufacturers targeting global markets, including India, US, and EU, benefit from our tailored regulatory solutions.
Our services align with CDSCO MDR 2017, EU MDR 2017/745, US FDA 21 CFR Part 807, and ISO 13485, ensuring global regulatory compliance.
Clients receive classification reports, TDF/CSDT dossiers, CERs, RMFs, and Authorized Agent representation documents.
Yes, our services are tailored to your specific device, market, and regulatory requirements, ensuring compliant and effective solutions.
We provide Indian Authorized Agent services, TDF dossier preparation, and CDSCO registration support to ensure seamless market entry in India.