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“Steve and QRx Partners brought a new level of intensity and scrutiny to our internal audits. They created a safe environment where they would debrief and discuss findings in a way that became teachable moments, which made our people think and become more engaged and take more ownership in the internal audit process. This has helped us to further strengthen our quality management system and be better prepared for external audits andinspections. Our engagement with QRx has also enabled us to better prepare our people to handle any QMS question, issues, or inquiries with confidence.”
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~ Russ Davies, VP of Quality and Regulatory
Apothecary Products, a provider of medication management, pharmacy supply, and home health care products
“Since joining Cirtec Medical, my priority has been to continuously evaluate and enhance our systems and processes to ensure robust quality and compliance. To support this, I engaged QRx Partners, leveraging my long-standing relationship with Steve and Mark, whose track record in compliance and efficient delivery is well-established.QRx Partners has been instrumental in a range of activities, from conducting internal audits, assessingprocesses such as CAPA and creating training, or managing improvementprojects like non-productsoftware validation. Their extensive industry knowledge and diverse skill sets ensure comprehensive and innovative solutions. Engaging QRx means gaining access to a wealth of perspectives and approaches we may not have considered. They consistently offer unique, customized services that integrate seamlessly into our existing processes without causing disruptions. This is precisely what I seek in a consulting partner: someone who can introduce new ideas and methodologies while maintaining harmony within our organization.”
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~ Michael Schnabel, VP, Quality Assurance & Regulatory Affairs
Cirtec Medical, a strategic outsourcing partner of complex medical devices, including minimally invasive and active implantable devices
"We’ve worked with Steve and QRx Partners since 2019, when they helped us secure ISO 13485 certification. Since then, they have proven a great partner. Along with helping us prepare for annual ISO inspections, they review our quality management system and make sure we adhere to the processes we've documented.
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“They also have provided training in root cause analysis and risk management that was a deep dive of what it entails at larger, more established companies. Steve offered many great stories and examples to make the experience more relatable. With subjects such as investigation planning or root cause analysis techniques, Steve kept it entertaining and interesting, so everyone remained engaged the entire time.
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“He is clearly, by nature, an educator. He likes to teach. And I've reached out to Steve several times just to run ideas by him, and he's always willing to help and provide advice."
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“The bottom line is he and QRx Partners are a pleasure to work with. They're always offering their advice and expertise. They are clearly passionate about quality and educating people about its importance.”
Chris Dulin, Quality Engineer
F&M Plastics, Inc., a plastic dip-molding and urethane manufacturing company that develops medical and health disposable products.
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“A quality system has an enormous breadth and scope in a medical device company because we're in a highly regulated environment. But the mistake some quality consultants make is to implement overly bureaucratic systems that don't add value. The difference between getting wrapped up in bureaucratic knots and proceeding efficiently is often times in the details of how the procedures are implemented. It's about how policies are written, what the requirements are, and who needs to be involved that really makes a difference.“ Mark Swanson and QRx Partners have the experience to understand what adds value and what makes a company compliant. When you have a deep understanding of both, you can implement quality systems that meet requirements without going overboard and bringing on unnecessary bureaucratic challenges.“VivaQuant is really good at designing products, but quality assurance systems are QRx Partners’ area of expertise. I've known Mark and QRx for quite a while, and we engage them to do things that they are superb at. He knows his craft and what’s required by the FDA and other regulatory agencies. They are an asset to VivaQuant.”
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~ Brian Brockway, President and CEO
VivaQuant, Inc., a digital healthcare company providing remote cardiac monitoring services to clinics and hospitals
"If I had to describe Steve and QRx Partners in three words, they would be focused, trustworthy, and informative."
“From our first conversation, it was evident I was speaking with a seasoned industry expert, someone we needed for our internal audit program. Their depth of experience was apparent in their detailed and unbiased work. Our staff gained a comprehensive insight into the current state of our QMS, along with targeted areas for improvement."
“What truly stood out was how Steve and his team presented their audit findings. The information was conveyed clearly, ensuring our staff fully understood how to enhance our QMS. It wasn't just an audit; it was an opportunity for growth, benefiting from both their extensive industry knowledge and instructional expertise—a true two-for-one package."
- Vice President, Quality Assurance and Regulatory Affairs,
Start-up Medical Device and OTC Drug Company (requested to remain anonymous)