Client Testimonials
Our work speaks for itself
Read what clients have said about their experiences working with MBCA
Our work speaks for itself
Read what clients have said about their experiences working with MBCA
“I had the pleasure of working with MBCA to prepare staff for an imminent FDA inspection. Melita was extremely knowledgeable and a superb coach. I continue to recommend Melita and her firm to both life sciences companies and to colleagues with world class regulatory and compliance skill sets.”
- Eric Henry, Sr. Quality & Regulatory, Boston Scientific
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.
- Sara Cahill, VP, Head of Quality
"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, Regulatory Compliance and Standards at Siemens Healthineers
MBCA was critical in shaping our understanding, training, processes, and documentation associated with FDA 21 CFR Part 820. Melita provided valuable input by reviewing our marketing material to ensure that we comply and understand how to present ourselves at conferences. Melita and her team have supported regulatory and clinical aspects of our upcoming clinical trial. Given the regulatory challenges, she will frequently provide options on how we can best proceed as a small company to meet deadlines while maintaining compliance. I highly recommend her for both start up and established medical device companies.
- Tom Reilly, Program Manager, Revolutionary Medical Devices, Inc.
“MBCA has been our go-to resource and partner for our Quality System and Compliance Needs. [Melita's] ability to "translate" the regulations across functional teams and at varying levels of maturity and understanding has made her services invaluable."
- Jade Kondo, Quality System and Compliance, Intuitive Surgical, Inc.
I have worked with MBCA for seven years and have the highest degree of respect for Melita and her abilities. She possesses a deep knowledge of medical device requirements and the regulatory climate that is not universal among consultants. She understands the intent of the regulations and readily shares this with her clients to teach them and improve their compliance. She not only appreciates the interrelationship of the QMS processes on a philosophical level but has the in-depth of knowledge to translate them into a quality management system that meets your company’s unique needs.
There’s nothing “cookie cutter” about Melita’s consultancy services: she is sensitive to her clients’ organizational needs and tailors her services to best meet them, whether they be a large, global organization (> 10,000 employees) or small startup (< 50 employees). Her ability to produce compliant solutions is evidence of her flexibility and solid comprehension of today’s regulatory environment. MBCA is adept at remediation and improvement initiatives. If you are seeking QMS guidance/training services, outsourcing internal auditing, or developing regulatory strategies, MBCA is a delight to work with.
- Erika Strickland, RAC, Medical Device Regulatory Affairs Professional
"I have brought MBCA in to work with us on our Quality System on several occasions because I like Melita’s streamlined approach to Quality. She and her team have breadth and depth of experience across a variety of medical device businesses that provides me with confidence that she is keeping us at the forefront of best practice. I recommend MBCA for anyone looking for consulting services in domestic and international Medical Device Quality."
-Sam Rua, SVP, Quality and Regulatory Affairs
Melita is a talented professional who makes quick and correct decisions. She is gifted with the ability to differentiate between important and less important in a way that both goals & timelines are met. Through my current position as a consultant, I’ve met dozens of persons in similar roles and no doubt Melita is one of the best that I've ever worked with.
- Gilad Kigel, eQMS on ServiceNow
MBCA actively supported RMD in developing our quality system, as well as auditing contract manufacturers and assisting in regulatory support for our medical products. Melita and her team are extremely knowledgeable, and they roll up their sleeves to get the job done. Melita is both patient and very instructive in outlining not only what needs to be done for a quality system, but why it is needed. We are very lucky to have found her and would recommend her to both start-ups as well as established organizations.
- Dave Kane, President & CEO, Revolutionary Medical Devices, Inc.
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