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  • Writer's pictureRanfac

Ensuring Compliance: Ranfac’s Commitment to Regulatory Certifications

Updated: Oct 3, 2023



Staying on the cutting edge of medical device manufacturing requires an unwavering commitment to the most stringent regulatory compliance and quality standards. These certifications play a central role in assuring customers and stakeholders that every device will perform flawlessly and maintain patient safety. Ranfac is well-known for upholding the highest standards of quality and safety during each step of our scalable production process, as demonstrated by our large portfolio of MedTech regulatory compliance certifications.


Topping the list of our compliance achievements is the MDR certification. Ranfac is one of only hundreds of medical device manufacturing companies in the U.S. that has obtained this certification in a timely manner. In addition to MDR, our legacy of ongoing compliance and product expertise is demonstrated and validated by:



An End-to-End Approach to Compliance


Staying compliant with these certifications and regulatory bodies is no simple task. However, our goal isn’t just to pass yearly audits. Instead, we integrate comprehensive checks into our process from the ground up to ensure every device obtains FDA approval and other relevant regulatory clearances. As a finished device manufacturer, our quality and regulatory personnel have full access to closely monitor every step of the process, both internally and externally. This ensures that, even after launch, Ranfac is the sole source of information and your go-to for post-launch inquiries. Moreover, our customers can immediately contact their dedicated project leader for updates, questions, or compliance assistance at any point in the process.


This framework guarantees that every step of the product life cycle, from design to post-market surveillance, adheres to the highest standards of quality and product integrity. Ranfac provides the best of both worlds in a one-stop shop: the decades of medical device expertise required to navigate the intricacies of compliance requirements, as well as the training and experience to efficiently record and store comprehensive documentation.


A Legacy of Compliance and Innovation


One of the hallmarks of Ranfac’s success is our emphasis on continuous improvement and innovation. For our team, compliance is not merely a box to check — it’s a cornerstone of the company’s commitment to producing cutting-edge healthcare industry solutions that deliver life-saving care. Every department, from design and development to production and distribution, holds regulatory compliance at the center of our operations.


By staying ahead of the regulatory curve, Ranfac opens the door to global markets while ensuring that our custom medical device solutions consistently meet the required safety and quality standards. From blue-chip OEM medical devices to small-scale contract manufacturing, Ranfac’s proven dedication to compliance is one of the many reasons our devices remain at the forefront of the industry.




CLIENT TESTIMONIALS

Without Ranfac, I would have failed. Failed to change a process that was affecting women negatively all around the world. Ranfacʼs COO, Barry Zimble, knew the importance of this. He knew the initial process as they were already working in this space, he could use the names of the original inventors but he understood the importance of changing the manufacturing. It was their deep experience in this field that was a really important reason to go for Ranfac. Bringing a new device is a journey and it is not a straight line, you canʼt plan everything and have it all to fall in line. It is a very bumpy process, and Ranfac really was there for us with every one of these bumps. They really stuck with us and were very creative with the solution to get us back on track. We kept throwing curveballs at them and they were incredibly resilient.
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NANCY CONFREY
CEO, Health Beacons (Acquired by Hologic)
Ranfac has supplied my company for over twenty years. We have developed a number of new products together and overcame many manufacturing and supplier issues over the years. It was always teamwork to resolve whatever challenge we incurred - no finger pointing or negotiation. It is so refreshing to share open discussions with the Ranfac team to provide quality solutions to our customers. Of course, Ranfac CO ,Barry Zimble, was always actively involved as the quarterback for the Ranfac team. He's always been realistic, pragmatic and candid as we worked through our challenges. His integrity is beyond reproach. If he commits his team to a goal, you can count on them.Over the years, Ranfac has continually re-invested in their equipment, facilities and their people. When I chose Ranfac as our primary supplier, it was one of the best business decisions that I ever made.
ALLAN DARR
CEO/ Owner ProAct, Ltd.

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