Christopher W. Holscher founded RedEdge Consulting in 2003. Chris has over twenty-nine years of accomplished medical device quality assurance and regulatory compliance experience.  He is an ASQ Certified Quality Auditor and is ISO 13485 Lead Auditor trained.  He offers in-depth experience with FDA & ISO regulatory requirements, including quality system compliance and submissions (510(k) and CE Marking).  He has successfully established and maintained the domestic and international quality and regulatory compliance program for several medical device manufacturers of disposables, electromechanical and implant devices. As a quality and regulatory compliance specialist, he assists medical device manufacturers with compliant quality system implementation, auditing and training. He supports quality leadership throughout client organizations providing education and promoting quality and regulatory compliance awareness. Mr. Holscher's primary goal is develop effective quality systems that protect the safety of client’s customers. While establishing RedEdge Consulting, Mr. Holscher also held management positions including Director, Quality Systems at Tenaxis Medical, Mountain View, CA. Tenaxis Medical develops high-performance sealants to meet needs in the vascular fields. Director, Quality Systems for Cardica, Redwood City, CA. Cardica manufactures anastomotic devices and micro-stapling devices. And, Director, Quality Systems / Regulatory Affairs for Solarant Medical, Inc. (formerly SURx, Inc.). Prior to establishing RedEdge Consulting he was Manager of Quality Systems for SURx, Inc., Livermore, CA. SURx developed and marketed a radio frequency generator/single use disposable applicator system for treating female stress urinary incontinence. Prior to SURx, Mr. Holscher was Manager of Quality Assurance for Aesculap, Inc. Aesculap is the largest worldwide supplier of surgical instruments. Aesculap designs and produces surgical instrumentation and implants for several surgical applications. Prior to Aesculap, Mr. Holscher was Senior Quality Systems Specialist for Cardima, Inc. Cardima develops and markets a radio frequency/single use disposable catheter based device for the diagnosis and treatment of cardiac arrhythmias. Prior to Cardima, Mr. Holscher was the Manager of Complaint and Medical Device Reporting for McGhan Medical Corporation, currently Allergan (previously Inamed Asthetics). Inamed Aesthetics is a global leader in the aesthetics device industry. Mr. Holscher is a seasoned veteran of the product development cycle in disposables, electromechanical and implantable devices. He has an expert background in Quality Systems development, regulatory compliance, internal audits, risk management, product development, document control systems, complaints and corrective actions, manufacturing operations, packaging, sterilization and supplier management for both large and small companies. Chris holds a Bachelor’s degree in Biology from Humboldt State University. He has been a member of American Society for Quality since 1990. Mr. Holscher has well established relationships with industry experts. He can put together a team to solve all of your quality and regulatory needs.