15/09/2024
🌟 We exhibited at Global Bio-India 2024! 🌟
We are excited to share that our company Tacit MedTek successfully participated in Global Bio-India 2024, held at Pragati Maidan, New Delhi. It was an incredible experience to connect with industry leaders, startups, innovators, incubations centers and visionaries in the life sciences sector.
As a trusted regulatory service provider, we specialize in offering comprehensive solutions across Medical Devices, Pharmaceuticals, Nutraceuticals, and Cosmetics industries. Our team is committed to guiding companies through the intricate regulatory landscape, ensuring compliance, and enabling smooth market access.
🤝 Thank you to everyone who visited our booth and engaged in insightful conversations. Together, we can shape the future of healthcare and innovation!
Contact: +91 +91 99678 24288 [email protected] [email protected].
At Tacit MedTek, we excel in providing comprehensive Regulatory Affairs and Quality Compliance Services for medical device and pharmaceutical companies.
Our Regulatory Services for Medical Devices Include:
1. CDSCO Registration.
2. CE Marking in compliance with the New EU MDR 2017/745.
3. Implementation of Quality Management Systems per ISO 13485.
4. Support for obtaining CDSCO licenses/permissions, including Medical Device import licenses, Manufacturing Licenses, test licenses, and clinical trial permissions.
5. USFDA Filing for 510(k), registration, and listing services.
6. Assistance with international medical device registrations, including Europe, Latin America (including Brazil), ASEAN, CIS, Africa, and GCC countries.
7. Preparation of Technical Files/Design Dossiers, risk management reports, and testing strategies for new products.
8. Guidance on global regulatory roadmaps for medical device startups.
9. Assistance in identifying predicate devices in India and developing Plant Master Files and Device Master Files as per the Medical Device Rules 2017.
10. Support in responding to queries from CDSCO, Notified Bodies, and other regulatory authorities in India.
11. Regulatory clearance support for Critical Care and Radiology (X-Ray and CT) products.
12. Development of creative regulatory strategies for non-device MDDS and CDS devices.
13. Coordination with international RA departments to develop innovative product launch strategies.
14. Proposing strategic options, effective communication with teams and management, and timely submission and approvals.
15. Integration of technical, clinical, and business objectives to ensure effective outcomes while maintaining high quality and ethical standards.
16. Reviewing and preparing software verification and validation documents, including regression testing.
17. Reviewing and preparing usability studies, IEC 60601 testing, risk assessment, biocompatibility, sterilization, labeling, and promotional materials.
18. Assistance in developing software for interfacing with keyboards and dual-line LCDs.
19. Integration of feedback systems to monitor X-Ray output intensity for patient safety.
20. Expertise in creating Regulatory Assessments/Global Regulatory Plans for efficient launches in US and OUS markets.
21. Experience in submissions for medical devices with mechanical, electrical, and software components.
22. Assistance with IFU and label creation/revisions, including translations and formatting.
23. Support for implementing processes based on FDA’s Cybersecurity guidance for Medical Devices.
24. Authoring Pre-Market Notifications (510(k)s), PMA-S, Design Dossiers, Change Notifications, and Letters to file.
