Profile: Novo Engineering specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO-certified (ISO 13485-2003) quality management system (QMS) covers a five-phase product development process from concept through manufacturing transfer, including controlled builds for preclinical and clinical trial devices. Our wide range of medical and non-medical devices, and our in-house development tools that include onsite rapid prototyping, CNC machining, and environmental testing are an asset to both our startup medical device clients and established product companies.
12 Products/Services (Click for related suppliers)
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• Biomedical Device Consulting |
• Biomedical Monitoring Device Development |
• Class I and II Medical Device Manufacturing Services |
• Common Surgical Instrument |
• Cryo Surgical Instrument |
• Custom Designed Medical Devices |
• General Surgical Instruments |
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• Hand Held Surgical Instruments |
• Medical Device Consulting |
• Medical Device Contract Manufacturing |
• Medical Device Designs |