I first encountered RQS and John Sawyer when he was recommended to us by our regulatory counsel. During my initial conversation with John, I was immediately impressed with his knowledge of quality systems and regulatory compliance. I was also impressed by the fact that he discussed how we needed to balance our compliance activity and business activity together hand in hand as a joint activity and what we needed to tell our employees and customers.
John quickly became an integral member of my executive team and was quick to put me and the team at ease on how to address the issues affecting the business. John always provided us with sound decisions on compliance issues and always had the reasoning and justification as to why we needed to take certain actions from a business and compliance perspective. Not only did he support the business from an FDA perspective, but also helped us with due diligence/acquisition activities and growth within our international markets and notified body.
John trained my executive team and all Veran employees on quality management systems as well as tested everyone to ensure retention by all. John established himself and proved to be a critical ally/supporter of our organization and worked tirelessly to accomplish all objectives that we agreed upon as a business. John & RQS has been associated with Veran for the past eighteen months. I would highly recommend to anyone needing the help that we did and know they would have a level of support and experience next to none.
While we each are looking at new endeavors, I will definitely use RQS and John in the future as I consider him part of my team and a valued resource.
Specifically, John and RQS did an exceptional job in helping us prepare for and supporting through our FDA inspection which resulted in a positive outcome for our company. John’s succinct and experienced advice was critical in helping our teams make the very best decisions throughout each phase. He is extremely thorough in his work and paired with his extensive experience and understanding of the FDA regulations I would encourage anyone looking for this type of support to use John as well. We certainly plan to use him and his team on going as they are now an instrumental part of our team.
| This is the first morning in a very long time that I have woken up without a thousand concerns going through my mind. Your guidance made this possible. While this has been a professional engagement based on expertise to solve a problem, it has been much more than this to me. You and Tom have given our team the knowledge and direction to have a chance to continue forward to provide a safe, quality solution to serve others at a time in their lives when they need help most.Beyond your knowledge, you provided a confidence and assurance throughout this entire process. While you have always been extremely clear that all we could do with each set of documents and requirements, was to do our best in assembling and then see how that information was received, you never pulled back or conceded doubt – even when I am certain you saw many situations where you had to be questioning how to possibly make the right moves on the board to get through this.This resolve and perseverance that you showed – to me – is the highest level of service that one person can offer another. It has been truly exceptional.I am deeply grateful to you for everything you have done and, hopefully, continue to do to help us move forward. |
|
For the past eighteen months, John Sawyer’s Company, Realistic Quality Solutions (RQS) has been a consulting partner with the Posey Company in the areas of supply chain issues, vendor audits and compliance, contract manufacturing audits and compliance, and auditing and training to FDA’s Quality System Regulations. When necessary, John helped refine procedures and work instructions, and assisted my management team with their implementation at our facilities in the U.S., Mexico. and China. John was able to work with our Quality and Regulatory team to get the job done without any friction. Often, due to the delicacy of their work. “outside consultants” are not able to develop a bond of trust and work with the “inside” team or make them recognize the necessary refinements and changes, and quickly move forward. John worked across our entire spectrum, from my office to the shop floor, to get everybody to understand the ‘big picture’ and the importance of making the changes now and in the future. As a result, we didn’t have any “turf wars” and everybody moved forward as a team. In order to cement all the of changes across our three plants, we brought in teams from China. Mexico, and my entire Management Staff in the US, for a week long training program on the FDA’s Quality Management System. Several of our vendors, whom John had worked closely with, also sent large teams to attend our class. I am confident that this very expensive training program will benefit our entire company, and help us ensure that the changes we have made over the past eighteen months will become a permanent part of our company culture. You can also count on John in a pinch. We ran into an issue with one of our European vendors, and John interrupted his Christmas vacation to visit their location for a strategic meeting and audit. John has become a valued advisor to our management team, and we will continue to use the services of Realistic Quality Solutions in the future. |
As a consulting partner with Eastek, RQS has helped us understand the complexities and best methods of applying the requirements of the Food and Drug Administration’s Quality System Regulation as we look to expand our contract manufacturing opportunities.
RQS has helped us create and edit procedures and work instructions, audit of our system and processes, as well as providing training where necessary. I like the name Realistic Quality Solutions, because, RQS has provided advice that is practical, effective, and makes good business sense.
Thanks to RQS we’re confident of our understanding of FDA regulations and our ability to manufacture safe and effective medical devices. We will continue our ongoing association with RQS.
https://youtu.be/B8K61C8rq-o
John and RQS has stayed current and on top of all standards relative to quality and regulatory compliance and it has been fun to work with someone from a clinical perspective who has a grasp of how these tasks interact with each other so that the patient, clinician, and manufacturer expectations are met.
Because of his experience and concern for all, I plan to continue my relationship and support for John & RQS, in completing clinical evaluations, non-significant risk studies, and Health Hazard Evaluations (HHE’s). RQS and I will remain strategic business partners.
I’ve been associated with John Sawyer and RQS for over eighteen years. During our working relationship at OEC Medical Systems, John Sawyer was instrumental in helping us quickly resolve an FDA Warning Letter. In a follow-up inspection by the FDA, we received zero observations. And in the years following, our inspections also resulted in zero observations. This allowed us as an organization to expand our product lines and markets with the confidence that all quality and regulatory requirements were being met.
As I have gone on to develop other business opportunities, I have continued my working relationship with RQS. John has helped us understand the regulatory complexities of the Food and Drug Administration’s Quality & Regulatory requirements as we’ve looked to launch our medical devices globally.
RQS stays current and on top of all standards relative to quality and regulatory compliance and has helped me with registrations, medical device listings and has helped me identify business partners in contract manufacturing.
Because of my continued association with RQS, I’m confident of my organization’s ability to manufacture safe and effective medical devices.
I have worked with John for most of my legal career, both when he held executive management positions in regulatory affairs (RA) and quality assurance (QA) at medical device companies, and subsequently as an independent consultant in RA and QA. John has a detailed command of U.S. and international RA and QA requirements. This knowledge is impressive in itself, but even more remarkable is John’s ability to integrate regulatory, quality, business, and practical considerations into a realistic plan that enables medical device companies to thrive and progress in the market in a legally compliant manner.
I always enjoy collaborating with John because he does things the right way but never loses sight of the client’s goals. Like his beloved Buffalo Bills, John is used to “playing” and succeeding under challenging conditions. He is the consummate professional.
Since its inception, John Sawyer and RQS have been a trusted partner to AMDR and many of its member companies, providing comprehensive guidance on FDA QSR requirements, ISO 13485 requirements, and MDD/MDR compliance for reprocessed medical devices. John and his team have actively contributed to drafting regulatory language for reprocessing considerations during the transition from the European Medical Device Directive to the EU Medical Device Regulation, as well as developing compliance matrices for various regulatory authorities. Additionally, RQS has supported reprocessors in understanding ISO 13485 certification process, securing 510(k) clearances, and addressing validation challenges under the FDA framework.
John is a recognized leader in regulatory compliance, quality system management, and risk management. Through his leadership at Realistic Quality Solutions LLC (RQS), John has played a vital role in advancing regulatory strategies for AMDR and its members since the inception of the commercial reprocessing industry in the early 2000s. Since 2019, John & RQS have been a Regulatory Advisor to AMDR, and this was reconfirmed at the beginning of this year.
John’s deep expertise in regulatory affairs, quality management, and risk management ensures that organizations can navigate regulatory requirements effectively while maintaining operational excellence. His ability to streamline quality processes, align global compliance strategies, and enhance regulatory readiness makes him an invaluable resource in the field of medical device reprocessing.
I strongly recommend John’s expertise to any organization seeking compliance leadership in FDA QSR, ISO 13485, and EU MDR. His contributions to AMDR have been instrumental in shaping sustainable, compliant reprocessing practices, ensuring that regulatory frameworks evolve to support patient safety and industry innovation.