ALLENDALE, N.J., March 17, 2021 /PRNewswire/ -- iNPLANT LLC, a medical device company and manufacturer of the iNPLANT Funnel, announced today that its parent company, Proximate Concepts LLC, has been awarded ISO13485:2016 certification for Medical Device and Quality Management Systems from SGS, the world's leading inspection, verification, testing and certification company. This ISO designation indicates that Proximate Concepts meets or exceeds the stringent quality standards required in the medical device industry.
The company's CEO, Paul Rosenberg, MD, explained, "Our team is proud and humbled to be awarded this certification, which illustrates Proximate Concepts' ongoing commitment to innovation and quality in the aesthetic plastic surgery community." The scope of ISO 13485:2016 certification includes design, development, quality assurance, quality management, product safety, customer service, and quality improvement.
"We are beyond excited to be at the forefront of aesthetic surgery innovation with this important ISO certification and to be able to contribute to the academic education and clinical improvement of outcomes for our colleagues in plastic surgery," explained Dr. Rosenberg. Toward this end, we are pleased to share that an article featuring the double loading technique with the iNPLANT Funnel, by Dr. Paul Rosenberg and President of the Aesthetic Surgery Research and Education Foundation (ASERF) Dr. Luis Rios, has just published in the award-winning open access journal Aesthetic Surgery Journal Open Forum, entitled "Double Loading of Breast Implants in Aesthetic and Reconstructive Plastic Surgery With the iNPLANT Funnel." The article and clinical videos illustrate the technical benefits of the iNPLANT funnel.
About iNPLANT LLC and Proximate Concepts LLC
iNPLANT LLC and Proximate Concepts design and develop surgical devices with a particular focus on the plastic surgery arena. Their flagship product, the iNPLANT funnel, is a disposable protective sleeve that permits the rapid and "no-touch" delivery of breast implants in patients undergoing cosmetic and reconstructive breast surgery, that contributes to lower complication rates. The interior surface of the device is coated with a lubricious substance which, when activated, dramatically reduces friction on delivery of the implant, avoids contact of the implant with the patient's skin surface, and minimizes contact between the implant and any bioactive substances on or around the operative site. iNPLANT LLC holds numerous US and international patents on several other devices in various stages of development. The launch of their novel suction drain system, FlatVac, is expected in Q3 of 2021. As with the iNPLANT funnel, FlatVac will also be manufactured under contract with Proximate Concepts LLC.