Enventure Technology Services, a leading Engineering and Environmental Compliance services provider, has been selected by a large Medical Device manufacturer in the USA to support their efforts to comply with RoHS 2 provisions.
Restriction of Hazardous Substances (RoHS) is a mandatory requirement as per a European Union (EU) directive (‘Directive 2011/65/EU’) for all manufacturers selling to EU countries. The directive restricts the use of specific hazardous materials found in electrical and electronic products and as per the recast version – RoHS 2, Medical Device manufactures who were previously exempt need to now fulfill the compliance requirements by July 21, 2014.
“The client awarded the corporate compliance contract, which includes all their divisions and product categories, to Enventure based on a successful pilot program in which we assisted the customer in getting the required documentation in place for one of their product lines,” said a spokesperson from Enventure. “We start out with customers by doing a Gap Analysis, to assess the maturity of their compliance program, and move on to identify the additional information that needs to be collected from the Supply Chain, to comply with RoHS 2”
“Subsequently, we collect and maintain information about the compliance status of each of their products and also provide support in proving that due diligence has been exercised and verification of material composition has been undertaken, prior to the Customer going for a CE mark. Further, we provide customers with documentation that can serve as an audit trail, in case they need to present that to RoHS enforcement authorities at a later stage.”
RoHS compliance is one among various compliance services provided by Enventure, and customers leverage other compliance offerings from Enventure such as for REACH, WEEE, Conflict Minerals and consulting services on managing compliance programs.