Product Safety, Quality, and Product Integrity professional with extensive experience in Quality Assurance and Product Integrity in many product areas including juvenile products, toys, and Class I & II medical devices.
– quality management system development
– industry-wide safety standards development
– regulatory compliance
– risk management / hazard analysis and prevention
– product verification and validation testing
– test laboratory management.
Technical experience:
– internal policies and procedures development
– root cause analysis and corrective / preventive actions
– regulatory agency reporting
– consumer complaint trending and analysis.
Member of the International Consumer Products Health & Safety Organization (ICPHSO). Member of ICPHSO Board of Directors 2018-2021. Member of American National Standards Institute (ANSI) Board of Directors 2019-2020. Member of ANSI Consumer Interest Forum. Member of ASTM International Committee F15 on Consumer Products.
BS, Mechanical Engineering and holds an MBA in Quality improvement from Xavier University
Founder of Alura Group. Lawyer and Senior Product Compliance Consultant with over 25 years of experience in product safety and conformity regulations and CE marking. Developed product safety legislation in 15+ countries. Since 1995, he has assisted more than a thousand companies of all sizes to get CE marking for their products. Han also has worked as a trusted expert in numerous legislative projects, helping governments of many countries to prepare legislation implementing new regulatory systems for products in their country. This helps him to thoroughly understand the regulations and their affect on businesses and processes.
Experiences:
Assistance in writing Laws and Regulations in Russia, Saudi Arabia, Turkey, Egypt, Albania, Bosnia Herzegovina, Croatia, Bulgaria, Moldova, Lebanon, Tunisia, Palestine and Morocco.
Author of 2 books and numerous articles on CE Marking
Founder and Owner of CEMarking.Net
I specialize in helping manufacturers, distributors, and Amazon sellers show Proof of Compliance to Amazon, Retailers, and Regulatory Agencies in markets where they sell their products. As a former importer and distributor of children’s products, I have walked a day in your shoes and understand how to help you to design and implement a consumer product safety program that is tailored to the way you do business. You need compliance processes and SOP’s that are adapted to how you work today, in a post-Covid world. I am a CPSC-approved Product Safety Coordinator and have implemented and monitored compliance programs required by consent decree by the CPSC and can help you with corrective actions for CPSC violations. Since 2011, I have been helping companies large and small, reduce their risk, protect their brands, and scale their business while maintaining ongoing proof compliance. Technology is a vital part of your compliance program and we help you implement the best solution to fit the way you do business.
Creator of CPSIA Ready.com – a Lab Independent complete CPSIA Solution for Business built around business operations and features “Compliance Consulting On Demand” and CPSIA U., a responsive e-learning platform for stakeholder and employee training related to CPSIA compliance.
Specialties: Approved CPSC Product Safety Coordinator
Amazon Seller P.O.C.
Product Safety Compliance Program Audits
Compliance Program Creation and Implementation
Business Operations and Supply Chain Compliance Readiness
Implementing Technical Solutions to Integrate Data into Compliance Programs
CPSIA / CPSC Compliance Readiness
M&As / Integrations / Startup Compliance Assessments
Member of ICPHSO
Masters Certificate – Project Management, George Washington University