I worked with MBCA on Pre-FDA audit prep activities/Mock Audit and in-house training. Melita provided the opportunity for first time SMEs to have an FDA prep- "hats on/hats off" auditing practice. Excellent support by Melita. Engaging, supportive and a great coach. Listened to our requirements carefully and delivered. She helped grow confidence/understanding in a real and practical way for SMEs. Result: Successful audit experience. Wrapped up one day early. ‍ Melita also ran in-house training to a targeted team on Medical Device Quality Auditor training covering Quality System auditing, audit phases & activities, tips & techniques, key auditing elements on QSIT GUIDE, 21 CFR Parts 803, 806, 820 & 11, Medical Device Directive (MDD), Canadian Medical Device Regulations (SOR/98-282), Brazil Ordinance RDC No. 16/2013, MHLW Ordinances 1 & 169, and ISO 13485. The course materials, case studies, and final assessment were all included. It was a good pace, and all team members gave very positive feedback on the 4.5-day course. Overall Melita attended to our requirements in a positive and very supportive manner. She was available to answer queries remotely if required. Good support, much appreciated. She listened and responded to her customer requirements, certainly helping to make our quality team increasingly effective for our business. ‍

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." ‍