While we are confident in our ability to bring outstanding quality products and services to you and your organization, you don’t have to take our word about it.
Our clients are thrilled with the value we deliver and the exceptional ISO certification services we provide, and they are always willing to share their experiences.
James B. Spencer, President / CEO, Arcamed
The purpose of this letter is to provide reference for, or more appropriately a wholehearted endorsement of Todd McBride of EBS Quality Solutions.
Arcamed is a medical device company established in November 2011. ISO13485 is a prerequisite for working with the majority of our target customers. We immediately began to use our network to find a consultant that would guide us in the development of our Quality Management System, and ultimately help us to achieve ISO13485 certification. We were referred to a number of consultants including Todd, and after interviewing all of them, we decided to work with EBS. This was the best decision we could have made!
We initially contracted with EBS to guide and oversee our development process. However, we quickly realized we simply did not have the internal capacity and/or capability to develop the system, and so asked EBS to take a more primary role in developing our QMS. Todd jumped right in, and began to work to “clean up” the work that had been completed, and to work with the Arcamed team to complete the development of our system.
After completing the QMS, Todd identified, interviewed and ultimately helped to engage our registrar (NQA), and our full time Quality Director. He worked with our ISO registrar to complete our Pre-Assessment audit and Stage I audit. He worked with the Arcamed team to “shore up” the findings from the initial audits, and then guided the team, and more importantly our new full time Quality Director through the Stage II audit. We passed our audits “with flying colors” and are now certified for both ISO 13485, and ISO 9001.
Our engagement with EBS could not have been more successful. They very aptly accomplished everything we asked them to do. Todd’s experience and knowledge in the areas of medical device and ISO Quality Management Systems are outstanding. He utilized an extraordinary ability to listen and quickly understand our business, as well as our company’s vision and goals. He incorporated this into our QMS development process.
In summary, Todd accomplished everything we needed, on time, and on budget. Quite simply… he nailed it! I highly recommend Todd McBride!
Amy Wortman, Director of Operations, Wolf Technical Services
We met with Todd in September of 2014 with a target certification date of Mar/Apr 2015. We had basic processes and procedures for quality in place, but very little formalized. Our company only has 18 employees and two that we were able to dedicate to the certification effort. To say that we were quite overwhelmed by the task at hand would be an understatement. However, after our initial consultation with Todd, we felt confident we were in good hands. He provided a basic timeline for achieving certification as well as a Statement of Work that broke the effort into 3 stages. Realizing that we also had some resource constraints, he included a price range for each stage based on his level of effort versus our ability to support the work needed to achieve our goals.
His previous experience, his knowledge and interpretation of quality initiatives, his no-nonsense approach, his guidance and his support were invaluable. He can think like a big company, but he can also think like a small business. He was very careful to understand what our business needed and made sure we did not back ourselves into a corner. I am happy to say we had our registration audit April 1&2 and passed with flying colors. It was a pleasure working with Todd. I call him our “Quality Guru”. I highly recommend his services.
Kevin Etzkorn, Managing Director, Heron Capital
I want to personally thank EBS and Todd McBride specifically, for all his efforts on behalf of Arcamed.
As a startup entity operating in the medical device market, securing ISO 13485 and 9001 certifications was a critical gating milestone for Arcamed’s growth and success. EBS’ expertise and diligence not only allowed us to gain these certifications but they were delivered earlier than scheduled and well within budget.
Building a robust Quality Management System is difficult enough when processes and procedures are already well established. This project was particularly challenging due to Arcamed’s status as a newly established entity with limited resources and dynamic internal processes. Despite the challenges, Todd’s expertise and knowledge of ISO Quality Management Systems was invaluable in establishing the project and system requirements. He then worked expertly with the team to develop an executable action plan leading to certification. While the details of the plan were complicated, I really appreciated the clarity with which Todd communicated the action plan, deliverables and timing to the entire team and management.
Finally, I want to mention how pleased I am with our new Director of Quality, Tony Adrian. Thanks to Todd’s efforts we were able to identify and recruit the perfect person to take the reigns and lead our quality program into the future.
Thanks again to Todd. It truly was a pleasure to work with him on this project and I hope we can find another opportunity to collaborate in the future.
Jeff Zuber, VP Sales and Operations, DVC
I first met Todd in my time as V.P. of Sales and Operations at DVC, Inc. Todd was the Quality Assurance manager at Roche Diagnostics and was assigned to bring our duplication/replication operation into Roche manufacturing compliance. Todd was instrumental in helping our staff compile SOP manuals and manufacturing processes that not only brought us into compliance, but also made our operations more streamlined and profitable.
Todd went way beyond the scope of his duties with Roche. Not only did he help our staff install quality control processes but he spent time learning our industry and educating our staff with the latest techniques for quality control and accountability thereby lowering our reject rate considerably. After work was finished at DVC, he stayed in constant contact offering new techniques that improved our quality and directly impacted our bottom line.
I highly recommend Todd to any company that is committed to Good Manufacturing Processes and wants to make a commitment efficient operations. Todd’s expertise is priceless.
Amy Harris, Quality Manager, Wolf Technical Services
Todd did a great job working with us to develop a quality system that would work for our company. He was able to assess our needs and assist in developing procedures that have made us a better and more productive as a company. He was very cost conscience knowing that we are a small business and had a tight schedule for getting certified. His knowledge of ISO quality systems is outstanding and he was able to clearly communicate the requirements as they apply to our business. Todd was able to take us through the entire process in 7 months.
I would recommend Todd to any large or small company looking to successfully develop a quality system that is tailored to whatever type of business you are. I know we would not have been able to do this without Todd and we will continue to utilize his skills as an auditor as we move forward.
Chris Reed, President / CEO, Cast A Bigger Net
Over the last few years I have gotten to know Todd. He brings a passion and relentless dedication to helping others and clients. He always goes way beyond what is expected when he engages with companies. He brings a depth of knowledge that goes beyond his industry to every customer interaction. Todd is someone who you can depend on. He is someone I trust. That is why I recommend Todd McBride without hesitation.
Tony Adrian, Director of QA, Arcamed
Todd provided exceptional support while developing and registering our ISO and 21CFR820 quality management system. As well, with his knowledge and experience with ISO, cGMPs, manufacturing, and medical devices, as well as business and industry best practices, he was able to coach, advise, and counsel our team on implementing a system that was effective and efficient from a business stand point and compliant to the ISO and 21CFR820 standards.