Al Pacheco and Associates, LLC has recently celebrated its 4-year anniversary, which also marks over 11 successful years for Al as a medical device Quality, Regulatory and Design Controls consultant.Services provided by Al Pacheco and Associates, LLC include:- Establishment of FDA and ISO 13485-compliant Quality Management Systems uniquely optimized for each business- Independent audits for FDA and ISO 13485 compliance including gap analysis report with actionable recommendations for maintaining ongoing FDA and ISO 13485 audit readiness - Management of FDA and ISO 13485 audits- End-to-end 510k submission support including submission strategy and possible pre-submission meetings- Act as Regulatory/QMS Quality/Design Quality department head up to the VP level- Provide Quality and Regulatory assessments and reviews for product delivery teams- Provide training and guidance in best practices for medical device design controls to product delivery teams- Manage FDA site and device registration- Manage FDA eMDR reporting- Manage FDA recalls- Assist with the preparation of Technical Files for EU MDR submissionsSummary of Al Pacheco’s background and experience:Al has over 25 years of experience in the medical device industry, including 8 recent years in digital health/SaMD, with a focus on Quality, Regulatory and software design controls. He has worked with major medical device, pharmaceutical and diagnostic companies in establishing and re-engineering Quality Management Systems to establish FDA and ISO-compliant, best practices. Al has an extensive track record working with innovative companies with a variety of SaMD, traditional electro-mechanical/software-controlled and IVD devices to achieve successful FDA 510(k) clearances and successfully prepare for and manage FDA and ISO 13485 audits. He has authored design control documentation for over 50 medical device product releases, over 25 successful 510(k) submissions and several CE Mark Technical Files.Al has a Bachelor of Science degree with Major in Management Information Systems from the University of Arizona and a Master of Science degree in Systems Management from the University of Southern California. His career has progressed from technical and management R&D positions with increasing responsibility, to a successful consulting career that has complemented that R&D background with extensive Quality, Regulatory and Design Controls compliance knowledge and experience.