Turnkey Medical Devices
Turnkey Product Engineering and Manufacturing Solutions Partner
Cogmedix is a rapidly growing US-based FDA compliant medical device contract manufacturer of Class I, Class II and Class III medical and clinical devices. Growth is the result of interest from medical device companies looking to decrease manufacturing costs without sacrificing quality, compliance, intellectual property protection, or patient satisfaction. Cogmedix enables medical and clinical device companies who want to engineer and manufacture products to do so without the expense of establishing their own production facilities, or to meet increased demand without increasing the existing physical plant. As an FDA compliant outsourced contract manufacturer, Cogmedix is able to provide reliable and regulated conditions for the safe and cost-effective production of today’s cutting-edge medical device technologies.
Reputable Medical Device Contract Manufacturer
The Cogmedix and its FDA compliant Cogmedix unit are widely recognized as a premier supplier of Class I, Class II and Class III medical devices to the medical and life sciences industries. With its FDA Registered Facility and ISO 13485:2016 certification through TUV SUD America, Cogmedix has established its leading reputation via operational focus and decades of experience in dealing with medical device product launches with rapid time to market expectations.
Compliant Medical Contract Manufacturing
Cogmedix provides its customers with the highest level of quality and compliance adherence in a tightly controlled QSR Part 820 compliant environment. The varied needs of its customers are consistently met by an experienced team where safety, compliance and focused Device History Record (DHR) management exist. With intense focus on new product introductions and its on-site clean room and high speed Printed Circuit Board Assembly (PCBA) lines, Cogmedix has been able to successfully and cost effectively list and launch new products for a broad range of medical innovation companies including, ADHD diagnostic kiosks, blood perfusion monitors, aesthetic lasers, home health care monitoring systems, and robotic braces used for rehabilitation therapy. Expertise in the medical device arena includes validation builds, scaled manufacturing, spare parts fulfillment and product refurbishment.
Cogmedix enables medical and life sciences companies who want to engineer and manufacture products to do so without the expense of establishing their own production facilities, or to meet increased demand without increasing their physical plant and employee count.