Requirement	Specification	Verification	Validation
1.The device must maintain proper alignment between the mandible and maxillary after the 6 week fixation period is complete	1.1 <2.0mm movement of the mandible due to bending parallel to the sagittal plane of the mouth	1.1 Apply tensile load analogous to force naturally produced by mastication muscle*Safety Factor (680N) to individual vertical mandibulomaxillary plates and measure deflection. Treat VMM plates as cantilever beams with point load at the unsupported end (mandible). Deflection must be <2.0mm. Maximum deflection will occur at the mandible	1.1 Apply same test method to completely assembled device after attachment to test mandible/maxilla.

Justification: 1.1- The maximum allowable movement of the mandible during the fixation period that constitutes “relapse” and justifies a follow-up procedure is 2.0mm

Requirement	Specification	Verification	Validation
2. The device must not interfere with the patient’s teeth and nerves	2.1 The device must be implanted in the intraradicular space between the 1st and 2nd premolars 2.2 Mounting holes must be included in the maxillary and mandibular potions of the device that allow screws to be implanted at a vertical distance of 5mm above/below the alveolar crest of the teeth 2.3 Diameter of mounting hole = thread diameter of screw (2mm)	2.1 Measure length and radius of curvature of arch bars. These dimensions dictate the horizontal position of screw placement 2.2 Measure length of vertical mandibulomaxillary plates after production. This length dictates relative vertical position of screw placement 2.3 Measure diameter of mounting hole. Place screw through mounting holes of individual parts before installation of full device	2.1 & 2.2 & 2.3 Mark on test mandible/ maxilla where safe implantation zones are located. Attach completely assembled device according to these markings. Safe implantation areas are represented by a 3.2mm diameter circle

Justifications: 2.1.1- The vertical dimension of the device must be large enough to include enough space for an MMF screw to be installed at a proper location
2.1.2- Upper fixation of screw must be above the root of the top teeth
2.1.3- Lower fixation of screw must be below the root of the bottom teeth
2.1.4- Screw placement must clear the root of the teeth by a minimum of 1.2 mm

Requirement	Specification	Verification	Validation
3. The device must fit comfortably within the space between the gums and the lips so as to not irritate the sides of the mouth	3.1 Specification: Depth of VMM plate + Arch Bar </= Height of MMF screw head (5mm)	3.1 Measure thickness of device after production. Thickness of device must be </=5mm	3.1 Use same screws as those used by other oral implant devices. (This cannot be directly tested without in vivo testing)

Justification: 3.1- Highest standard MMF screw head = 5mm = Maximum protrusion of device from the area of implantation

Requirement	Specification	Verification	Validation
4. The device must not induce clinically relevant local or systemic inflammatory response	4.1 The device must be constructed out of a material that is not corrosive/harmful to the patient (e.g. Stainless steel, Titanium, Aluminum, Polyurethane, etc.) during the time period of usage 4.2 The device will be constructed out of a material that is not biodegradable	4.1 & 4.2 Compare material properties with information regarding their biocompatibility found in literature and appropriate standards (e.g. ASTM A276 Standard Specification for Stainless Steel Bars and Shapes)	4.1 & 4.2 Compare the behavior of the device with that of pre-existing devices made from the same materials. Live subject testing cannot be conducted for this project.

Justification:4.1.1- Chemical reactions between bodily fluids such as blood/saliva could harm the patient by changing pH and releasing toxins
4.1.2- Materials such as the ones mentioned corrode in the body at a slow rate due to their relatively non-reactive chemical behavior
4.1.3- This device is only to be implanted for 6 weeks, which is not enough time for 316L Stainless Steel to corrode significantly

Requirement	Specification	Verification	Validation
5. The device must accommodate to patient needs in terms of size by being manufactured in several sizes	5.1 The selected device’s dimensions must scale with measurements made by the surgeon via oral region x-ray of patient mandibular profile	5.1 Organize patient mandible/maxilla dimensions into demographics. Scale forces exerted on device based on size comparison to original device. Variations made in components’ dimensions must scale with variation found in mandible and maxilla dimension between demographics	5.1 Design one version of the device for each demographic in order to accommodate for each one of them. All versions of the device must meet requirements 1-4.

Justification: 5.1- There is a wide range of mandible sizes in the target market. One potential size of this device may fit one patient but not properly fit another