IDS Hires Regulatory Consultant

Identification Solutions has engaged Dr. Timothy Stein as a Regulatory Consultant to help guide the company initially through the CE Mark (Europe) regulatory process and later through the FDA (USA) regulatory process. For the last 20 years, Dr. Stein has been the owner of Business Performance Associates Inc., a firm located in Cupertino, CA and has guided over 110 clients through the CE Mark/FDA processes since then. His firm will help provide IDS with software design development processes that are compliant with IEC 62304:2006, design control requirements (QSRs and ISO 13485); FDA guidance documents for submission, preparation of documentation for 510(k) submission for products that include software, and testing of medical device software.  His goal is to help IDS achieve software regulatory compliance.