"Without a doubt, Melita and her group were the best consultants I have had the pleasure of working with during 30 + years of Medical Device/Combination Products design, manufacturing, sterilization and distribution. I consider Melita to be an expert on Quality Management Systems as well as the Regulations and Standards that govern it. Her auditing resulted in clear and concise opportunities for improvement and her group’s software development/validation/delivery and Service are second to none."-- Kevin O'Reilly, Senior Manager Regulatory Compliance and Standards at Siemens Healthcare DXWe are Life Sciences Consultants serving Class I, II, and III Medical Device companies, Biotechnology companies, and Pharmaceutical companies around the world.MBC & Affiliates, Inc. (MBCA) is a full service Life Sciences consulting firm specializing in Quality Systems and regulatory compliance solutions. Our Life Sciences experts have the real world experience it takes to formulate the right compliance solutions for your unique situation. We partner with our clients to help with everyday needs like managing key suppliers, performing supplier audits, performing internal audits, and being an extra set of hands during high volume business needs. We are also there to help you tackle your most challenging regulatory compliance situations like responding to 483's and Warning Letters and leading cross-functional remediation projects. Continued success in this highly regulated industry is certainly not easy but with knowledgeable medical device consulting partners at your side, your regulatory compliance risks are reduced and your Quality Management System and business performance will positively reflect your commitment.Our model for success: - Long term relationships with our clients - Consistent, practical compliance solutions that work! - Creating high performing Quality Management Systems that support business performance - Reduction of regulatory compliance risk - Improve company's standing with the global regulators⇛ ⇛ SET UP A FREE 30 MINUTE CONSULT WITH MELITA ⇚ ⇚ ⇛ ⇛ mball@mbcaconsulting.com or (520) 665-9081 ⇚ ⇚