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:

Regulatory Planning

  • Our expertise in identifying applicable harmonized standards, common standards and compliance testing standards helps derive a perfect impact assessment plan.

Impact Assessment & Gap Analysis

  • With assessment criteria selection including assessment for FDA, device classification, portfolio impact assessment and so on, we help you overcome the flaws and gaps while maintaining the overall objectives of legal framework for compliance.

Regulatory Remediation

  • Expert regulatory remediation assistance for regulatory requirements consolidation and tech documentation creation, realignments, rewrites and reviews helps you to execute the correct compliance remediation.

Safety and Compliance Test

  • QuEST assures integrated, strong and safe compliance tests with labs to facilitate tests like compliance with IEC 60601x, pre-compliance testing (electrical), and EMI / EMC for products to help deliver highly efficient solutions.

Post-Market Support

  • We offer technical documentation relevant for post-market requirements, benefit-risk determination, labelling, CAPA support, field safety and corrective actions, and product recall management solutions for OEMs as 360-degree support process.

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:

  • Minimize product development costs and time to market
  • Innovate workflows and IT infrastructure with an all-inclusive multidisciplinary approach
  • Integrate your products with latest technology standards, platforms and devices, to boost interoperability, connectivity and customizability

Deep Learning: The Greatest Technology Trend in Radiology
Deep learning has been the buzz word in the last few years and it actually presents a lot of probabilities…
case Study
Interested in learning more?
Contact Us