Regulatory Expertise for Medical Devices

• CDSCO Submissions: Expert guidance and support for CDSCO filings, including Import Registration, Manufacturing Licenses, Test Licenses, Market Standing Certificates, Non-Conviction Certificates, and Free Sale Certificates.
• Periodic Safety Update Reports (PSURs) and Risk Management Reports: Meticulous preparation of PSURs and risk management reports to monitor and address product safety concerns.
• GSPR, SSCP, and Technical Files: Thorough development of General Safety and Performance Requirements (GSPR), Summary of Safety and Clinical Performance (SSCP), and comprehensive technical files to demonstrate compliance.
• Validation (IQ, OQ, PQ): Development and execution of comprehensive validation protocols (Installation Qualification, Operational Qualification, Performance Qualification) for your medical devices.
• Device Master File (DMF) and Plant Master File (PMF): Preparation and maintenance of DMFs and PMFs to provide detailed information about your devices and manufacturing facilities to regulatory authorities.
• Post-Market Clinical Follow-Up (PMCF): Design and implementation of PMCF studies to monitor real-world performance and safety of your devices after market launch.

Theta Wave Device Services

• Biological Evaluation Plan and Report: Creation of comprehensive biological evaluation plans (BEPs) and reports (BERs) to assess the biocompatibility and safety of your theta wave devices.
• Toxicology Risk Assessments (TRA): Thorough assessment of potential toxicological risks associated with your theta wave devices, ensuring patient safety.
• Clinical Evaluation Report (CER): Preparation of CERs that summarize clinical data and demonstrate the safety and performance of your theta wave devices.
• Gap Assessment by ISO 10993: Evaluation of your device’s compliance with the ISO 10993 standards for biological evaluation of medical devices, identifying any gaps and providing remediation strategies.
• Biocompatibility Study Design: Design of biocompatibility studies tailored to your specific theta wave device, adhering to ISO 10993 and ISO 18562 standards.
• Biological Evaluation: Conducting in-depth biological evaluations of your theta wave devices to assess their interaction with biological systems.

Why Choose Us?

• Proven Track Record: Successful submissions and approvals for a wide range of medical devices, including those utilizing theta wave technology.
• Technical Expertise: Deep understanding of medical device regulations, quality standards, and the specific requirements for theta wave devices.
• Client-Focused Approach: Tailored solutions to meet your unique needs and goals, ensuring a smooth and efficient regulatory pathway.

Partner with us for the safe and compliant development of your theta wave devices and other medical technologies.

Let’s connect to discuss how our expertise can support your innovation.