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:
- ISO 13485:2016
- MDSAP
- EU Quality Management System
- CGMP/QSR
- FDA
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.
