#USA #Avon #Cervos Medical #KeyPRP System #Ranfac Corp

Cervos Medical Receives EU MDR Certification for CERVOS® KeyPRP System

Cervos Medical, a subsidiary of Ranfac Corp, is celebrating a major achievement with the receipt of the European Union Medical Device Regulation (MDR) certification for its CERVOS® KeyPRP System. This certification marks an important step forward in ensuring the safety, quality, and performance of their advanced medical device, which is set to enhance the landscape of regenerative medicine across Europe.

The CERVOS® KeyPRP System has undergone rigorous evaluations to meet the stringent requirements set by the EU under Regulation EU 2017/745. By obtaining this certification, Cervos Medical confirms its unwavering dedication to delivering safe and high-quality medical devices that healthcare providers can trust.

Michaela Gates, the Quality Assurance Project Manager at Ranfac Corp, expressed pride in the team’s effort, stating, “Obtaining the CE (MDR) certification for our Platelet Separator is not merely about adhering to regulations; it showcases our commitment to safety and compliance. With this credential, we are eager to tap into new markets in the EU and witness our growth trajectory.”

The significance of this certification extends beyond regulatory adherence; it validates Cervos Medical’s mission of providing innovative regenerative solutions to clinicians. The CERVOS® KeyPRP System will now be available in Europe exclusively through Aspire Medical, which serves as Cervos's official sales partner in the European market. Eric Kreuz, Vice President of Quality Assurance and Regulatory Affairs at Ranfac, emphasized that this marks a new era of opportunities for the company. “This certification affirms our ongoing commitment to product excellence and ensures patient safety. With Ranfac's strong backing, we can successfully introduce innovative regenerative technologies to a wider audience in global markets,” he stated.

The CERVOS® KeyPRP System is a state-of-the-art device designed for autologous tissue processing. It specializes in the extraction of platelet-rich plasma (PRP), bone marrow aspiration, and adipose tissue processing. As Cervos Medical continues to lead in the field of regenerative medicine, its focus remains on developing minimally invasive technologies that assist clinicians and improve patient outcomes.

As part of the Ranfac family, Cervos Medical is underpinned by over a century of expertise in medical device manufacturing. Based in Avon, Massachusetts, Ranfac Corp has built a reputation for trust and quality in the healthcare sector.

With the successful receipt of the EU MDR certification, Cervos Medical is poised to not only expand its market reach in Europe but also to contribute to the advancement of regenerative medicine by providing doctors with the tools they need to improve patient care effectively.

In conclusion, Cervos Medical's achievement signifies a commitment to innovation and excellence in medical devices. The EU MDR certification of the CERVOS® KeyPRP System opens the door for further advancements within the field and showcases the company’s ability to align with the highest regulatory and performance standards in the industry. As they embark on this new chapter, the focus remains on enhancing the quality of healthcare through state-of-the-art technology, ensuring a healthier future for patients around the globe.