Chicago, IL Sep 02, 2021 – ComplianceXL will develop strategies and deliver tailored services to optimize and fulfil Regulatory Compliance needs for a global medical technology company in Europe. Using advanced assessment methodologies, and tech enabled supplier engagement. ComplianceXL is expected to increase business agility, reduce supply chain risks, and meet global compliance needs across regulations such as EU RoHS, REACH, Prop65 and EU MDR.

The client is a global leader in manufacturing cardiovascular devices for clinical health care markets in interventional cardiology, cardiovascular and vascular surgery, and critical care. The client has a global sales footprint and is entitled to be compliant with all major regulations.

By leveraging two decades of regulatory compliance expertise, ComplianceXL will implement best global practices in the compliance management process. The comprehensive managed solutions include:

  • Developing a detailed Compliance roadmap covering stages such as Gap Assessment, Design Compliance Framework, Training, Technology Implementation, Compliance Documentation, and on-going maintenance
  • Assessing the current levels of compliance, review existing process and systems
  • Designing a robust strategy based on observations and chalk out a compliance framework
  • Creating awareness amongst by conducting training covering all internal and external stakeholders
  • Revamping existing processes and reporting methods to instill best practices from peer groups and stay ahead of competition
  • Managing the overall Compliance Documentation process by implementing a cloud-based technology platform.
    • A Dedicated supplier engagement team will gather compliance documents for thousands of parts from over 500 suppliers across time zones
    • The documentation is supported by a software that acts as centralized repository of compliance documents such FMD and CoCs
    • The team can manage multilingual documentation across various regions
    • Covering all major regulations such as EU RoHS, REACH, Prop65 and EU MDR Documentation

The multi-year contract helps the client with scalability, a faster time-to-market, transform supply chain process, and build a value case that guides its business roadmap development, and drives continuous innovation.

“We are excited to be part of compliance management for a global med-tech company, simplify processes and support providing connected real-time data. The Managed Compliance Solution from ComplianceXL provides the client with the ability to focus on its business more than ever before and reduce supply chain risks,” says CK Bharathan, Head of Compliance Solutions at ComplianceXL.