FDA Compliant Manufacturer

Cogmedix is widely recognized as a premier manufacturer of Class I, Class II, and Class III medical products to the medical and life sciences industries.

Medical Device Contract Manufacturer You Can Trust

Cogmedix is a rapidly growing US-based FDA compliant contract manufacturer of medical devices. Growth is the result of interest from medical device companies looking to decrease manufacturing costs without sacrificing qualimedty, compliance, intellectual property protection, or patient satisfaction. Cogmedix enables medical 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 medical device 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 Manufacturing

FDA compliant Cogmedix is widely recognized as a premier manufacturer of Class I, Class II, and Class III medical products to the medical and life sciences industries. With its FDA Registered Facility and ISO 13485:2003 certification through TÜV SÜD America, Cogmedix has established its leading reputation via operational focus and experience in dealing with medical device product launches with rapid time to market expectations.

Medical Device Contract Manufacturing for Various Applications

Cogmedix provides it customers with the highest level of quality and compliance adherence in a tightly controlled FDA QSR compliant environment. The varied needs of its customers are consistently met by an experienced team where safety, compliance and focused Design 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) capabilities, 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, dental lasers, imaging devices, 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.



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