1. Preparation of CE Dossier
This service involves compiling all necessary documentation and information required for obtaining CE (Conformité Européenne) marking, which indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
We will compile and structure technical documents, testing reports, clinical data (if relevant), labeling details, General Safety and Performance Requirements (GSPR), Summary of Safety and Clinical Performance (SSCP), Design and development plans, and any other documents too. These efforts aim to showcase adherence to the applicable EU directives and regulations.
We will compile and structure technical documents, testing reports, clinical data (if relevant), labeling details, General Safety and Performance Requirements (GSPR), Summary of Safety and Clinical Performance (SSCP), Design and development plans, and any other documents too. These efforts aim to showcase adherence to the applicable EU directives and regulations.
2. Preparation of DCGI Dossier
This service focuses on preparing the dossier required for obtaining regulatory approval from the Drug Controller General of India (DCGI) for medical devices, or other healthcare products.
We’ll assist in compiling all necessary documentation, including Device master file, Essential checklist, IFU and Labeling information, and any other relevant information required by the DCGI.
We’ll assist in compiling all necessary documentation, including Device master file, Essential checklist, IFU and Labeling information, and any other relevant information required by the DCGI.
3. Preparation of ROW Market Dossier
This service involves preparing a dossier tailored for submission to regulatory authorities in markets outside of India and the EU, commonly referred to as Rest of World (ROW) markets.
We’ll help compile a comprehensive dossier containing all necessary documentation and information required by regulatory authorities in specific countries or regions, ensuring compliance with their respective regulatory requirements.
We’ll help compile a comprehensive dossier containing all necessary documentation and information required by regulatory authorities in specific countries or regions, ensuring compliance with their respective regulatory requirements.
4. Preparation of Risk Management Plan/ Report
Risk management is essential for ensuring the safety and effectiveness of medical devices. This service involves preparing a comprehensive risk management report, which identifies, evaluates, and mitigates potential risks associated with the use of the product.
We’ll assist in conducting risk assessments, implementing risk controls, and documenting the entire risk management process in accordance with relevant international standards and regulatory requirements
We’ll assist in conducting risk assessments, implementing risk controls, and documenting the entire risk management process in accordance with relevant international standards and regulatory requirements
5. Preparation of DHF (Design History File)
For medical device manufacturers, maintaining a Design History File (DHF) is a regulatory requirement in many countries. This service involves compiling and organizing all documentation related to the design and development of a medical device.
We’ll help gather and organize design input requirements, design verification and validation records, design changes, risk management documentation, and other relevant information to ensure compliance with regulatory requirements.
We’ll help gather and organize design input requirements, design verification and validation records, design changes, risk management documentation, and other relevant information to ensure compliance with regulatory requirements.
6. Artificial Intelligence Prompt
This service involves leveraging artificial intelligence (AI) technologies to enhance various aspects of regulatory document preparation and compliance.
We can provide AI-driven solutions for tasks such as document classification, data extraction, quality control, and automation of repetitive tasks, ultimately streamlining the regulatory submission process and improving efficiency.
We can provide AI-driven solutions for tasks such as document classification, data extraction, quality control, and automation of repetitive tasks, ultimately streamlining the regulatory submission process and improving efficiency.