Your Trusted Partner for Medical Device Clinical, Quality and Regulatory Services
Techsol specializes in offering value-focused medical device clinical research services powered with innovative GxP technology solutions to global sponsors who develop different classes of medical devices across therapeutic areas. Our MedTech team has extensive domain knowledge and practical experience in handling of end-to-end complex global trials and working with US FDA, EMA, PDMA, SFDA, Health Canada, DCGI and ROW for regulatory approval submissions.
Our expertise covers a wide range of medical device classes and study types, including but not limited to FIM studies, prospective CE Marking RCT (blinded / unblinded), and Post-Marketing Clinical Follow Up (PMCF) studies.
With an unwavering focus on quality, patient safety and regulatory compliance, we have successfully delivered end-to-end Clinical Trial Services, Pharmacovigilance, Medical Device MDR Compliance and Regulatory Services to multi-national medical device organizations.
At Techsol, Quality Management and Compliance Oversight is an integral part of our all business operations right from the clinical trial design to final report generation. Our corporate quality team strives to ensure that are processes and technology platforms are aligned towards international standards and 100% compliant to global and local regulations.
We have the following Quality Certifications to Account for Our Process Excellence
Our Capabilities
- Experienced team: Our team has over 20+ years of combined experience in the medical device industry, supporting clients to successfully bring their innovation to market.
- Comprehensive services: We offer end-to-end services to support your clinical, quality and regulatory business needs for medical device development, launch and post-marketing.
- Customized solutions: All our services are personalized based on the therapeutic area, medical device class and regulatory obligations to meet your specific needs.
- Regulatory expertise: Our team has a deep understanding of the regulatory requirements and can help you navigate the complex regulatory landscape.
- Modern Technology: We leverage the modern, purpose-built and validated technology platforms to deliver high-quality services
- Transparent Project Management: We understand the criticality of go-to market timelines and our team is fully committed to support your medical device launch success.
