We assist you in obtaining ISO 13485:2016 certification , the internationally recognized standard for quality management systems in the medical device industry, ensuring that your processes meet the required standards for safety, efficacy, and regulatory compliance.

We guide you through the process of obtaining FDA approvals for your medical devices, including 510(k) notifications and Premarket Approvals (PMA), ensuring that your product meets the stringent safety and efficacy standards set by the US Food and Drug Administration.

Achieve CE Marking for medical devices, demonstrating compliance with the European Union’s regulatory requirements and facilitating access to the European market.

Obtain the necessary wholesale distribution licenses for your pharmaceutical or medical device products in India, ensuring compliance with local regulations.

We specialize in creating and remediating Risk Management Report and GSPR , ensuring that your medical devices are fully compliant with ISO 14971 and other relevant regulations.

We assist in the preparation of your Plant Master File (PMF) and Device Master File (DMF) in accordance with the Indian Medical Device Rules (MDR) and global market requirements, ensuring your product documentation is comprehensive and compliant.

Obtain the necessary wholesale distribution licenses for your pharmaceutical or medical device products in India, ensuring compliance with local regulations.

We help you navigate the regulatory landscape to obtain the import license needed for importing drugs or medical devices into India, complying with Indian Drug and Cosmetics Act.

Obtaining a license for manufacturing Class A and B (MD-5) or Class C and D (MD-9) medical devices is a key regulatory requirement in India. This license ensures compliance with safety and quality standards, enabling legal production and distribution while demonstrating adherence to India's medical device regulations and commitment to public health.

From regulatory guidance to operational support, we assist startups in establishing a compliant medical device manufacturing setup, ensuring smooth entry into the market.

We help you ensure that your Design History File (DHF) is compliant with the required regulations and industry standards, helping you address gaps in your documentation and bring your product to market.

We assist in preparing PSUR reports, Post-Market Clinical Follow-Up (PMCF) documentation, handling PMS complaints, compiling investigation summaries, and submitting MDRs, ensuring your processes meet required standards and regulatory compliance.

We fuse innovative strategies with compliance to meet the healthcare sector's needs, offering a manufacturing site plan, cleanroom production facilities, and comprehensive documentation and validation services. Collaborate with us to bring your medical device ideas to life, from design to production, while we assist you in navigating compliance for global markets, including pre-market approval submissions.

We assists clients in creating comprehensive and thoroughly documented reports that are vital for the regulatory approval process. These reports emphasize the safety and efficacy of medical devices, playing a crucial role in obtaining market access.

Our Training and Education services are crafted to equip clients and their teams with the expertise and skills required to excel in the intricate domains of regulatory compliance, quality assurance, clinical trials and medical device Trainings with Complete Training Frameworks, Adapted to Suit Client Specifications, Accreditations and Certifications.

The Central Drugs Standard Control Organization (CDSCO) is India’s National Regulatory Authority (NRA) for cosmetics, pharmaceuticals, and medical devices. It operates under the Directorate General of Health Services, Ministry of Health and Family Welfare. To ensure safety, the Indian government has mandated CDSCO regulation for medical devices, cosmetics, and contraceptives. CDSCO approves product quality and issues licenses for critical drugs, including blood products, vaccines, injections, medical devices, and sera.

Streamline your medical records with concise summaries focused on essential information, arranged chronologically for a clear medical history. Our thorough case analysis identifies potential issues and inconsistencies, enhanced by customized reports with visual aids and annotations. With a team of seasoned medical experts, certified coders, and legal professionals, we ensure every record is meticulously examined. Leveraging years of experience, we deliver precise analysis and reporting. Each case is unique, so we provide personalized solutions tailored to your needs, whether for legal proceedings, insurance claims, or medical audits.