Enable Injections Awarded ISO 13485:2016 Certification

Enable Injections Inc., developer of the advanced enFuse large volume wearable injectors (LVWI) platform for subcutaneous delivery of biologics, has been awarded the International Organization for Standardization’s (ISO) 13485:2016 certification for its Quality Management Systems.
 
The new certification verifies that across the company’s operations and manufacturing, Enable Injections’ quality system and processes meet the rigorous regulatory requirements and comprehensive reviews of ISO 13485:2016 certification for medical devices and related services. These include design, development, production, manufacturing, storage and distribution at all device lifecycle stages.
 
“As demand for our enFuse drug delivery platform accelerates, our pharma partners can be assured that Enable Injections is committed to designing and manufacturing the highest quality, most advanced and most patient-friendly biologics delivery technology,” said Michael D. Hooven, Enable Injections president and CEO. “With our pharma partners, we are dedicated to improving the patient infusion experience to increase compliance, improve outcomes, and reduce health system costs.”

Biologic drugs dominate pharmaceutical company pipelines but due to their viscosity and the large doses required, at present most require intravenous (IV) administration in a costly healthcare facility.
 
Enable’s wearable devices, while supporting delivery of life-saving products in the hospital, have the greater potential to shift treatment to the patient’s home or office by providing easy and comfortable patient self-administration of doses as large as 50 ml. For the pharmaceutical companies developing biologic therapies, enFuse’s automated functions can reduce drug development time by months or years.
 
During 2017 Enable Injections entered into new clinical and development collaborations with current and new patient-focused pharmaceutical company partners to develop novel combination therapies that also ease treatment for patients with life-threatening or chronic diseases.
 
Founded by medical device industry veterans, Cincinnati, Ohio-based Enable Injections develops and manufactures wearable devices that allow easy, comfortable patient self-administration of large volume/high viscosity drugs in doses from 4 ml to 50 ml. The Enable body-worn enFuse drug delivery platform utilizes any standard container closure system, including syringes or vials; automatically warms and can automatically mix lyophilized solutions. Enable’s devices are available for pharmaceutical and biotechnology industry investigational use.