Rudy Zacher, MS has a background in medical device engineering primarily in the subjects of Research & Development, Manufacturing, and Quality Assurance at all device stages from initial development through regulatory submission and product distribution. His areas of focus include: Design Control subject matter expert including project technical leadership and management of Design History Files; Risk Management subject matter expert including implementation of Hazard Analysis and Risk Management systems compliant to ISO 14971: 2019; Establishment and implementation of Quality Systems with compliance to FDA QSR and ISO 13485; pre-clinical product Verification & Validation; Device Master Record development establishing manufacturing methods, supplier chain, and lot history records for device traceability; and medical device concept design and development. He has particular expertise in the field of ophthalmology with extensive work in intraocular lenses and cataract surgical devices. He holds MS and BS degrees in Biomedical Engineering from California Polytechnic State University.
Regulatory Pathways Group Inc.
a California corporation
Inquiries and general information:
info@regulatorypathways.com
