Enventure has been selected by a leader in medical device manufacturing to transform compliance documentation for global regulations

Enventure has signed a contract with a leading medical device manufacturer in the US. Under the blanket agreement, we will reform existing practices to modernize compliance documentation and help comply with RoHS, REACH, WEEE, EU MDR & Prop 65 regulations.

The client is a leading medical device company that has been at the forefront of innovation in medical technology for over 50 years. They pioneered intra-aortic balloon pump systems and catheter technology. The company’s products are used by hospitals and clinics around the world to treat patients with heart failure, cardiac arrhythmias, and other cardiovascular conditions. Globally, it has become a trusted partner for healthcare professionals.

Enventure combines its two decades of compliance expertise with a managed compliance solution to help clients mitigate risks around the globe. The client will receive a comprehensive plan and implementation strategy for resilience in their compliance documentation process from a dedicated team of compliance engineers, supplier engagement specialists, and project managers. The scope of managed compliance services includes:

• A cloud-based software platform to manage compliance documentation and act as a centralized repository for all compliance documents. With this platform, clients can easily integrate their ERP/EAM systems for a thorough and streamlined compliance process. The software platform helps to automate the compliance process with its user-friendly interface, ensuring that all compliance documents are up-to-date and stored securely.
• A team of supplier engagement specialists to gather all the necessary compliance documents such as Full Material Disclosure, Certificate of Conformity, and others from suppliers across the globe.
• A dedicated team of Compliance engineers to analyze and validate suppliers’ responses and update the compliance data in a cloud-based software platform. Compliance engineers range from experts in RoHS, REACH, WEEE, and EU MDR regulations to update and modernize existing compliance documentation.
• Enventure offers its clients efficient component engineering on a scalable cloud environment, and dedicated component engineers dedicated to delivering the project. By combining these software and engineering expertise, the client will be able to accelerate its component engineering efforts and improve efficiency in production and compliance.

While the contract is signed and set to run for several years, the first year of this engagement holds a much greater purpose, including software implementation and supplier engagement. As part of our compliance management efforts, we aim to transform and modernize the compliance documentation for RoHS, REACH, WEEE, MDR & Prop 65 while also providing training to both internal and external stakeholders. It will mark a significant milestone in our journey towards achieving the objectives.

“At Enventure, we believe in equipping our clients with the best technology to help them stay ahead of ever-evolving regulatory regulations. By taking the step towards material compliance management, our clients will gain a competitive edge and be well-positioned to make the most of future opportunities.” says CK Bharathan, Head of Compliance and Master Data Management, Enventure.