product engineering

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Contract Manufacturing

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Medical Devices

Cogmedix Services

• Medical Device Contract Manufacturing
  • Class I & Class II Medical Device Manufacturing
  • Medical Lasers
  • Trained, Certified & Experienced
  • Medical Device History Records
  • Cost Conscious Manufacturing
• New Product Introduction (NPI)
• Documentation Refinement
• Process Validation
• Storage & Fulfillment
• Refurbishment & Repair Depot

About Cogmedix

• Our Team
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Medical Lasers — Laser Manufacturing

Lasers and LEDs are increasingly integrated into a wide range of medical products, including various diagnostic and imaging systems, skin treatment applications, ophthalmic assessment and surgical procedures, and other applications such as those used for removal of kidney stones via surgical laser.

Many of the lasers used in medical devices are Class 4 lasers, so ensuring your medical device contract manufacturer has the appropriate handling and safety measures in place is paramount. Cogmedix will meet your needs in our laser safe facility and is ready to discuss your laser based medical product manufacturing needs today. Other laser based medical device applications are outlined in the table below.

Ophthalmic vision correction photocoagulation of the retina glaucoma laser surgery corneal collagen cross linking vision assessment and diagnosis		Skin/Dermatology/Cosmetic tattoo removal skin rejuvenation skin resurfacing hair removal non invasive cellulite reduction laser liposuction stretch mark treatment scar treatment wrinkle treatment
Surgical & Other Treatments laser surgery for kidney stones laser spine surgery vein treatments teeth whitening laser podiatry

Class 4 Lasers

There are four major laser hazard categories in the United States, ranging from Class 1 Lasers (Class I) to Class 4 lasers (Class IV). Class 4 lasers are the most powerful class of lasers, thus appropriate handling, safety and compliance are critical. Cogmedix operates a registered Class 4 laser facility, compliant with the requirements of American National Standards Institute Z136 Guidelines and 105 CMR 121.000.

Laser Safety — Medical Device Manufacturing

At Cogmedix, all subassemblies and finished devices that contain a laser are powered up and tested only in our designated and secure laser test room, which has the appropriate signage and eyewear requirements posted clearly. The Cogmedix laser safety program is overseen by our Laser Safety Officer, who has received training from an independent third party laser organization.

Cogmedix is a medical device manufacturer of Class I and Class II medical devices, some of which integrate laser and LED technologies. As a subsidiary of Coghlin Companies, Cogmedix provides medical contract manufacturing services for companies seeking a compliant, conscientious, cost effective, domestic medical device contract manufacturer to assist them in manufacturing medical lasers.

Coghlin Companies completed the transition of the legacy product line over a nine-month period and simultaneously developed a New Product Introduction (NPI) plan which included developing precise documentation, capital equipment contract manufacturing of medical devices, quality control inspection, functional testing, packaging and world-wide fulfillment.

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