Compliance Management for market access and regulatory requirements for product manufacturers is becoming more complex each year. Organizations large and small are confronted with a flood of workforce and compliance-based requirements driven by laws, contractual obligations, industry standards, and additional risk factors. Industries are anticipating more government regulations to emerge that will have a significant impact on business decisions. Whether disclosing your conflict minerals due diligence, detailing hazardous substances or ensuring the absence of child labor in the supply chain, new legislative and regulatory requirements are going to increase in the years to come.
Our services meet specific industry needs and provides continued market access and reduced risk to business. We are your one-stop solution providers for knowledge, tools and services for all your product stewardship and regulatory compliance activities. Our experienced cross-functional teams provide holistic solution for organization’s regulatory compliance needs. We offer off-the-Shelf & tailored solution for specific industrial requirements. We help our customers follow agile project management approach for faster deployment of solutions.
Hardware Regulatory Compliance
Regulatory Compliance for Electronic Hardware (end-use devices and systems) is spanning more engineering disciplines to ensure ‘Total Compliance”, The top two that many companies have issues with are EMC (ElectroMagantic Compatibility) and Product Safety (NRTL/CB Scheme). With 30 years of compliance experience, we can help you design for compliance, prepare for and/or manage the testing process and ensure you receive all the international approvals in a timely manner. We manage specific aspects of: EMC (Radio/Telco), Product Safety and FDA Affairs for Medical Devices. In addition, we can manage Energy Efficiency (Testing and Intl Registrations), Environmental Simulation (Mechanical/QA Testing), RoHS/REACh compliance and Conflict Minerals sourcing. We provide QMS Do Control and Archive services in addition to drafting DoC’s and TCF’s. For Europe, we can manage your ReUse/Recycle requirements (WEEE, Packaging Directive and Battery Directive). There are many more ways we can help, but let us know what Regulatory Requirements you may have and we’ll detail how we can help.
Are you “compliance” ready?
Learn how Acnovate can be your partner to build a sustainable compliance program that goes a long way to provide strong foundation for governance, risk & compliance management and generates faster ROI while getting your product to market faster.
Our compliance focused services are available for,
Conflict Minerals Compliance (Dodd Frank Act Section 1502) Services
REACH Compliance Services
Restriction of Hazardous Substances (RoHS) Compliance
End-of-Life Vehicles (ELV) & GADSL Compliance
WEEE Compliance
GHS & REACH Safety Data Sheet (SDS) Services
Bill of Material (BOM) Assessment Services
EMC (ITE, Radio, Telecom and Medical Devices)
Product Safety (ITE, T&M, Audio/Video, Power-Supplies/Inverters and Medical Devices)
Energy Efficiency: Testing and Registrations
Environmental Simulation (IP ,Mechanical & QA testing)
ReUse/ReCycle Requirements: EU (WEEE, Battery and Packagind Directives)
International Type Approvals (Radio and Telecom)
Agency Interface including (FCC, FDA, NRTL, BSMI, VCCI etc…)
Regulatory Roadmaps & Fulfillment/Management( scoping the project from Concept to Certification)
Market Driven Certification (Bluetooth, WiFi and Pacemaker/Defib Telemetry testing
Customized Declarations of Conformity (DoC’s) and Technical Construction Files (TCF’s)
Design Reviews: PreComplinace Assesments, Construction Reviews, Debug Assistance