Medical device companies are quickly embracing the new normal by adapting to the rapid market changes. The key drivers for growth today are regulatory compliance, faster deployment cycles and higher operational efficiency.
The ever-evolving and stringent regulatory timelines for compliance within 2020 (MDR) and 2022 (IVDR) are prompting medical device manufacturers to perform new conformity assessments in sync with the dynamic rules. Significant changes in the European Union regulations, replacing directives to regulations viz. MDR and in-vitro device regulation (IVDR) and the mandatory unique device identification (UDI) requirements are urging Original Equipment Manufacturers (OEM) at large to focus more on portfolio rationalization and harmonizing QMS.
Our streamlined compliance processes empower medical device manufacturers and OEMs to reduce workarounds by deploying comprehensive engineering support in areas like pre-clinical validation, regulatory compliance, cybersecurity & privacy, quality systems & processes, product certifications & compliance also product safety & usability.
Our product development services are focused around:
Impact Assessment & Gap Analysis
Safety and Compliance Test
QuEST collaborates with its clients for mapping your work-streams and performing do-buy analysis, and eventually creating a strategic partnership roadmap. We build Centers of Competencies (CoC) to drive successful engineering solutions for your device development workflows. Our constant endeavor is to: