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Value Creation For Your Medical Device Development Project…2x Faster Than In-house Development

REV•1 ENGINEERING REV•1 Engineering gets you to market with a quality product much more quickly than building a start-up in-house team. We are an independent, owner-operated medical device product development company. We handpicked our experienced, full-time staff to put your project on hyper-speed.Everyone at REV•1 Engineeringis driven to succeed for you…From the top down!

The newoutsourcingparadigm…Start-ups that run as “virtualentities” with low capitalexpenditure combined withvariable-cost outsourcepartners, like REV•1Engineering, allow foundersand early investors to carrythe company further andretain more ownership.This results in higher returnsand stronger value creation atan earlier stage in yourmedical device development.

REV•1 ENGINEERING CAN START TODAYREV•1’s deep experience allows us to quickly and confidently estimate your project's costs and time lines.Within a few days after an initial meeting, REV•1 will deliver to you a presentation-ready, detailed Critical Chain Project Planand PowerPoint proposal. You can now confidently review your project costs and timeline with your investors, Board, orpotential strategic partners. The day we receive your approval, we immediately implement your plan to reach your milestones and build your corporate value… long before you could put your own infrastructure and team in place.

2 HEADS EQUALS 10Our full-time team members bring a surprising range of skills and resources to your medical device product development.Averaged across your entire project, you may need 2 resources, but the reality is sometimes you need as many as 10 ormore resources when you are pushing toward an important milestone. REV•1 flexes it's resource allocation for yourproject from 1 to 10 or more to meet the project objectives, offering a variety of skills including: Program Management Materials Engineering Design Engineering Process Development Product Assembly CNC Machining Injection Molding Rapid Proto-typing Finite Element Analysis Quality Engineering Clinical Engineering Regulatory Specialists Due Diligence/Acquisition Support

OUR FULLY EQUIPPED FACILITY doctors, investors and regulators. It becomes YOUR office for the dayAt REV•1 Engineering, we own our facility and thesophisticated equipment required for all research & REV•1 team members are adept at hosting meetingsdevelopment activities, rapid prototyping, CNC machining, with all stakeholders, offering product demos andquality control, and inspection. impressive facility tours highlighting the rigors of our development process.Our “virtual entity” clients also use our facility toshowcase their product development process for

YOUR ALLY FOR YOURPRODUCT DEVELOPMENTFUNDINGREV•1 typically takes its clients through FDA and CE Markapprovals before it is necessary for the client to build acommercialization team. Most of our successful clients do nothire full-time employees, other than C-level management, prior toseries C funding.By creating a fast and capital efficient model, REV•1 puts youquickly on the road to an acquisition or funding of acommercialization plan. With REV•1 on your side, you have anally who understands the funding challenges you face… and howto overcome them with high-speed, high-quality productdevelopment.

MITIGATING RISK REV•1 Engineering drives technical, clinical and business risk out of the product development cycle, by moving quickly through to a proof of feasibility phase review of your design. 3D designs are confirmed with actual prototype builds occurring over multiple iterations. Bench testing, clinician-use testing, and early in-vitro and in-vivo tests ensure that your design needs, in their fundamental forms, are met before moving into further development and cost.

REV•1’s QUALITY SYSTEMPROTECTS YOUR INVESTMENT Our staff has years of experience working under quality system controls. If your start-up needs a quality system, REV•1 will customize and implement a proven and scalable Quality System. With our proprietary project management protocol as a foundation, REV•1 creates meticulous development records and oversees the documentation of your medical device product design in a Design History File to ensure a smooth approval process.

REGULATORY APPROVALSIMPLIFIEDYour Design History File (DHF)is created in real time during the designthrough development and verificationthrough validation phases. This DHF isthe foundation for your FDA or CE Marksubmission.REV•1 also develops and/or managesyour pre-clinical and clinical testingrequirements, creating alldocumentation necessary forsuccessful regulatory approval.

TRANSFER OFMANUFACTURING REV•1 always designs products with manufacturing efficiencies in mind. We develop and improve all manufacturing processes in house. We are then ready to drive the transfer of your manufacturing process quickly to a domestic or international manufacturer. Whether you have a manufacturer in mind, need some recommendations or want to build \"in-house\", REV•1 will transfer to and support your manufacturing team. Often ramping up production in parallel with the regulatory review and approval period, allowing you a quick launch after approval.

POST LAUNCH SUPPORTREV•1 Engineering is happy tocontinue to offer servicesduring your product's life cycleor help you with next generationproduct development. Once ourclients have experienced 2xFaster medical device productdevelopment, they bring us newideas or new market segmentsthey’d like developed. We arealways ready to pick upwhatever post-launch supportyou need.

Become our nextsavvy entrepreneurIf you have intellectual property on a technology that has greatmarket potential, clinical need, and you understand the medicaldevice funding path, REV•1 can partner with you as yourcomplete R&D team. You’ll now have plenty of time to work onfurther funding activities and management of your start-upwhile we handle all of your product development needs.You need the support of an R&D partner who understands howto bring your product to market with quick and innovativedevelopment. You can achieve your goals 2x Faster with REV•1Engineering on your side.Please open an exploratory conversation with us by eithercalling (951)-696-3933 or sending us an e-mail [email protected] describing your needs.