Chicago, IL; September 15, 2019 – ComplianceXL is helping a North American Medical Devices manufacturer in their supply chain risk mitigation and material compliance obligations requirements The engagement will cover the entire spread of global compliance regulations such as EU RoHS, EU REACH, CA Prop 65, Medical Devices Regulations, EU Pops, Canada SOR/2014-254, EU Packaging Directive and Natural Rubber Latex compliance data for their complete products/parts in the PLM and ERP systems.
The client is a leading manufacturer of medical devices in the North American region, with footprint over 60 countries across the global. The client is specialized in minimally invasive stereoscopic (3D) camera for Neurosurgical, ENT, Arthroscopy and Laparoscopy applications; they are the first to develop 3D-HD System with endoscopes in small diameters.
ComplianceXL will run a full managed compliance program that will aggregate, validate, load and maintain all supplier declarations in a central repository. ComplianceXL will constitute a team of compliance engineers who will engage with suppliers to acquire all the necessary information as required by respective compliance regulations.
The objective is to gather Full Material Declaration for all parts in the supply chain. Further the data is validated to verify the compliance status of each part:
- Presence of EU RoHS substances as per directive EU 2015/863
- Applicability of RoHS exceptions
- Presence of Substances of Very High Concern (SVHC) in chemicals as per EU REACH
- Presence of substances as defined under CA Proposition 65
- Substance CAS Number, content and safe harbour data
- Presence of CMR or endocrine disrupting substances
- Presence of Mercury or Mercury compounds
- Presence of Natural Rubber latex
- Presence of Pb, Cd, Hg and Cr (VI) in the packaging material
ComplianceXL’s deep expertise in delivering robust supplier engagement programs will benefit from a more secure, scalable and agile supplier communication and compliance documentation. The multi-lingual supplier engagement team at ComplianceXL will engage with suppliers across the globe, at various time zones and ensure accurate compliance documentation. Furthermore, on-demand training is provided to all supply chain stakeholders and ensure proper documentation of compliance records.
A web-based proprietary tool – partlinq – by ComplianceXL will enable multi-channel communication and makes the data collection easier. The data flow is controlled by AI enabled algorithms that automates most common parameters and validates compliance information as required.
“This approach of combining multi-lingual offline engagement team with an AI enabled online tool will deliver a competitive advantage on a secure platform, enabling the client to accelerate compliance documentation and achieve superior supply chain sustainability”, says C K Bharathan, Head – Compliance Solutions, ComplianceXL.
This is a multiyear engagement with the client to cover their entire supply chain and mitigate risks related to global compliance regulations.
About ComplianceXL:
ComplianceXL is the Compliance Solutions Division of Enventure, a leader in the compliance business since 2003. ComplianceXL is a one-stop solution for all supply chain compliance requirements, ranging from consulting and training to collecting compliance certifications and documentation from suppliers. By implementing a transparent and well-structured compliance program, ComplianceXL enables clients to follow an integrated process, to meet their compliance obligations. Beyond an initial implementation, ComplianceXL also provides ongoing support to maintain compliance to regulations such as RoHS, REACH, CA Prop65, Conflict Minerals, ELV, GHS/OSHA and several other global legislations.