In today’s rapidly evolving regulatory and quality assurance landscape, medical device companies struggle to comply with regulations across nations. Businesses are not only stretched for bandwidth of in-house resources who may lack expertise on how the regulations are changing, but also on their implications. Non-compliance leads to product recalls, legal costs, and can impact a company’s brand.
Cyient has helped over 12 medtech firms seamlessly comply with new regulations, establish or enhance the quality management system, and enable internal resources to focus on their core expertise. Our experienced team has successfully launched medical devices in multiple countries, including USA, Europe, India, Singapore, and Canada, in accordance with local regulatory requirements. We have established, documented, and maintained an effective quality management system that meets the requirements of ISO 9001 and ISO 13485:2016. In addition, we are actively helping customers successfully comply with EU Medical Device Regulations (MDR) and In-vitro Diagnostics Regulations (IVDR).
We have established a Regulatory Center of Excellence for one of the top IVD companies, supporting them to comply with In-vitro Diagnostic Regulations (IVDR).
Established a successful remediation engagement with a US-based Top-5 orthopedic company. Remediated 28,000 SKUs for implants, instruments, cases, and trays within 15 months to ensure compliance with FDA standards.