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I already have complete 3-D CAD files for a novel vaginal pessary and a full set of dimensional and tolerance drawings. What I still need is the bridge from screen to sterile tray: a small run of physical units that match those specs and are safe for first-in-human use. Material The design is intended for medical-grade silicone; I am open to fluorosilicone if it better meets our chemical-resistance requirements. You’ll need to confirm biocompatibility (ISO 10993) and document any additives or colorants you plan to use. Scope of work • Review my CAD and tolerance stack-ups, suggest any refinements that improve moldability without altering the clinical function. • Select or design an appropriate fabrication process (rapid-tool injection molding, LSR casting, or another method you can justify). • Produce and ship an initial batch of prototypes—enough for bench testing and a pilot clinical run. • Supply a brief technical report: material certs, process parameters, dimensional inspection against my drawing, and recommendations for scaling to a larger GMP run. Acceptance I will sign off once the samples arrive dimensionally within the stated tolerances, pass a basic cytotoxicity screen, and the documentation package is complete. If you’ve taken similar class-II devices from CAD to clinic, especially in silicone, your insight will be invaluable.
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75 freelancere byder i gennemsnit £362 GBP på dette job

Hello there! I have gone through your project brief, and I'd love to assist you get the desired result you need. I see you tagged 3D CAD, Biomedical Engineering, Mechanical Engineering, Solidworks, 3D Printing, CAD/CAM, Medical Engineering and 3D Modelling. Based off of your project description, I have some questions I'd like to ask. Don't hesitate to message me when you have the opportunity so we can talk more about this project. Best regards, Daniel Etie
£300 GBP på 4 dage
7,5
7,5

As an extremely experienced mechanical engineer with a firm grasp on sophisticated CAD software like Solidworks, CATIA and Abaqus, I believe I could be the perfect fit for your project. With extensive knowledge regarding the design and development of medical-grade products, I understand the utmost significance of absolute precision and compliance in ensuring the safety and efficacy of an object like your pessary prototype. I have been involved in several projects similar to yours where I've taken class II devices from concept to clinical trials, including working with silicone-based components. My familiarity with fabricating methods using rapid-tool injection molding, LSR casting and more can help us choose the best process for your desired silicone design as per clinical requirements. My skills also cover material selection and ensuring biocompatibility (ISO 10993), something crucial for your project. At the end of our collaboration, you can expect comprehensive documentation, dimensional inspection records, and suggestions for scaling up based on a potential GMP run. To boost my engineering work, I can integrate my 3D modeling skill to give you a visual representation of your prototype. A partnership with me will not only ensure detailed technical aspects of your project are rightly addressed but also secure a friendly professional who would be devoted to delivering nothing short of perfection.
£260 GBP på 3 dage
7,8
7,8

Hello, As a seasoned engineer with vast experience in complex medical device development and fabrication, I am confident in my capability to fulfill your pessary prototype needs. Being conversant with ISO 10993 biocompatibility regulations and extensive knowledge in materials, especially medical-grade silicone, rests at the core of my skills. My proficiency in Solidworks and CAD/CAM guarantees that I can closely examine your files, suggest refinements for enhanced moldability whilst ensuring clinical functionalities are retained. In addition to my expertise in 3D Modeling and Mechanical Engineering, I bring a wealth of knowledge on the selection or design of appropriate fabrication processes. I believe that the right fabrication process can make all the difference between a mediocre product and one that meets—and surpasses—customer needs. With this in mind, I commit to delivering prototypes fabricated through reliable methodologies such as rapid-tool injection molding on time and within stated tolerances. At Live Experts®, we respect the importance of documentation. Therefore, alongside delivering an initial batch of prototypes suitable for bench testing and pilot clinical runs, we will provide you with an exhaustive technical report comprising material certifications, process parameters, dimensional inspection against drawings as well as recommendations for scaling up. In essence, choosing me means selecting a tested capability gu Thanks!
£750 GBP på 6 dage
7,2
7,2

Hi there ! With over 8 years of expertise in 3D Modelling, CAD/CAM and Mechanical Engineering, I am confident that my skills align perfectly with your project requirements. To address the scope of work outlined, I have substantial experience in designing and manufacturing products using various materials, including medical-grade silicone. Not only can I review your existing CAD designs to ensure optimal moldability without compromising clinical functionality, but also propose the best fabrication process for your pessary prototype. In addition to my technical capabilities, I am extremely detail-oriented and have a critical eye for quality control. This means I can meticulously adhere to the tolerances you've specified and will provide thorough documentation for each prototype produced aligning with international standards such as ISO 10993. Lastly, I understand that this project requires not just technical proficiency but also a deep grasp of safety regulations and scaling up. Having previously taken similar class-II devices from CAD to clinic, I have developed an understanding of the unique intricacies involved which would be invaluable to the successful completion of your project. In short, if you choose me for this important task, rest assured that you'll be getting a dedicated professional committed to delivering impeccable results at every stage- from design to production-ready samples.
£250 GBP på 2 dage
6,8
6,8

Hi,I am mechanical design engineer. I have 11+ years of experience in product designing ,3D CAD modelling , Step file designing,Sheetmetal manufacturing ,cnc and laser cutting, reverse engineering,stl and step file creation. My skills are Solidworks, Autocad, Catia,Nx-CAD, CAD/CAM, etc. I have read and seen your project and would like to know more through the conversation. i had designed many prototype for manufacturing. I am expert in AutoCAD and solidworks and my expertise is perfectly aligned with your requirements. I will deliver 3D CAD model with technical (Blueprints)drawings and STL files. Any confidential details and files will not be disclosed to any one. if you want see my sample work please check PDF and images on my Profile or i will send through chat. I will wait for your response. Regards. ABHAY
£300 GBP på 7 dage
7,0
7,0

As a seasoned 3D CAD specialist with a focus on mechanical engineering, I am well-versed in the exacting demands of translating detailed design plans into precise physical prototypes. I have not only worked extensively with SolidWorks, but also nurtured notable competence in using various fabrication processes - precisely the kind of expertise you require. My familiarity with rapid-tool injection molding and LSR casting, among other methods, puts me in good stead to select and justify an appropriate process for your pessary prototype.
£266 GBP på 1 dag
7,4
7,4

Welcome I MADE MANY SMART DEVICES THAT MANUFACTURED AND USED IN REAL YOU WILL GET IT DONE PERFECTLY IN LESS TIME CHECK MY LATEST REVIEWS > (http://www.freelancer.com/u/ENG1mga) I have previously worked on, Lifting Set of Drones Mechanism, Robotic Arm, Delivery Robot, Automatic Wiring Machine, Solenoid Engines, Car Rooftent, Boat Lift Mechanism, Shoe Treadmill Mechanism Mechanical Ventilator and many other projects. I use Solidworks, Fusion 360, and ANSYS, COMSOL I have a workshop specializing in all 3D printing and CNC machining work, so I strive to provide the highest quality and precision. What you will receive with me: - 2D drawings - 3D files - Complete Tech. Formats - Finite Element Analysis (FEA) (if needed).
£250 GBP på 2 dage
6,8
6,8

Hi there! I can support the transition from CAD to clinical-ready silicone prototypes, including DFM review, process selection, and documentation. I have done similar jobs before. ✅ Which regulatory pathway are you targeting (FDA 510(k), CE MDR, other)? ✅ What quantity is required for the initial pilot and bench testing phase? ✅ Do you already have a preferred ISO 10993-tested silicone supplier? Portfolio: www.freelancer.com/u/rvwebfreelancing/mech I look forward to your clarification and the opportunity to collaborate professionally. Best, Rahul Buildtrix Studio
£255 GBP på 4 dage
6,4
6,4

Hello, I am leading an American Licensed Engineers team with expertise in Structural and Civil Engineering. We excel in wood, concrete, and steel structures, providing detailed designs and safety analysis. For the Pessary Prototype project, we will review your CAD files, refine moldability, select suitable fabrication processes like rapid-tool injection molding, and produce prototypes for testing. Our experience in biomedical engineering and 3D modeling ensures precision and compliance with ISO 10993. Let's collaborate to bridge your design to a trial-ready prototype. Cheers, RedBrick American Engineering
£250 GBP på 1 dag
5,9
5,9

HI there, Drawing on our extensive experience in 3D modeling and a deep understanding of the manufacturing process, I am confident that we are well-positioned to take your Pessary Prototype project from CAD to clinical. Our proven expertise includes translating digital models into physical products that meet stringent industry standards. With over 400 projects completed, we have ample experience with similar class-II medical devices and can ensure your design's moldability without compromising its clinical function. Further, we are well-versed in silicone fabrication methods; including rapid-tool injection molding and LSR casting, thus familiar with the chemical resistance and biocompatibility you require. This will help us to confidently select the best method for your project. In addition, we have an in-house quality control process that ensures precise dimensional inspection against your drawings, guaranteeing that the prototypes will arrive within your specified tolerances. Your satisfaction is our priority - so let us navigate the journey from screen to sterile tray, producing top-notch prototypes for bench and clinical testing - saving you time and helping to move the project along swiftly and smoothly. We are excited about this opportunity to work together - let's turn this fantastic design into safe, patient-ready product!
£250 GBP på 2 dage
6,0
6,0

Having successfully translated various CAD designs into physical prototypes for real-world applications, I bring to the table eight years of extensive experience that directly aligns with your pressing project needs. My expertise centers around the same class-II devices and materials you're dealing with, especially silicone, giving me an in-depth understanding of the intricacies involved in ensuring biocompatibility, regulatory compliance, and precision molding. You can rest assured that I'll meticulously review your CAD drawings, suggesting any refinements to enhance not just moldability but also preserving the clinical functionality you've designed. My familiarity with rapid-tool injection molding, LSR casting, and more means you can trust my discernment in selecting or designing the right fabrication process to achieve trial-ready prototypes. As an added advantage, I leverage highly-efficient tools like SolidWorks and AutoCAD for streamlined workflows that save time without ever compromising quality. Let us embark on this exciting multidimensional journey towards creating a safe and effective vaginal pessary prototype. The scope of this project truly fascinates me; let's exceed even your highest expectations together!
£252 GBP på 2 dage
6,4
6,4

Hi there, I am a SolidWorks & Fusion360 expert, product designer and mechanical engineer. I checked your project details carefully and I have a great interest in your project. I am confident that I can bring your specific ideas to life. Here is my service; ✨Creating STL, STEP and X_t files for 3D Printing and Manufacturing. ✨2D technical drawings for manufacturing. ✨Create a DXF and PDF file for CNC/Laser/Plasma cutting. ✨3D modeling/rendering of assembled parts. If you hire me, then your project will be completed more successfully. I am waiting for good news. Best regards Belal
£250 GBP på 1 dag
5,7
5,7

Hello Harris P., I understand that you require assistance in transitioning your 3-D CAD files for a vaginal pessary into physical units suitable for first-in-human use. I will review the CAD files, suggest improvements for moldability, select an appropriate fabrication process, produce prototypes for testing, and provide a detailed technical report for your review. Please have a look at our Freelancer Portfolio through the links given below. =================================== https://www.freelancer.com/u/CreativeDesign50 =================================== * Deliverable Format Web & Print. AI PNG EPS PDF PSD JPG With expertise in 3D Modelling, 3D Printing, and CAD/CAM, I am confident in delivering high-quality prototypes. Effective communication during UK hours will ensure a smooth collaboration. Looking forward to your positive response to establish a mutually beneficial business relationship. Best regards, Kirandeep K.
£250 GBP på 3 dage
5,9
5,9

Hello, With over 8 years of experience in 3D modeling, specializing in 3D printing, asset creation, visualization, and prototyping, I am confident in my ability to bring your pessary prototype project to life. I have successfully managed projects similar to yours and have a great deal of expertise in this area. I am well-equipped to review your CAD files, suggest improvements for moldability, select the appropriate fabrication process, and produce a batch of prototypes for testing. You can view examples of my previous work in my portfolio here: https://www.freelancer.com/u/BLADESTYLE I would love to discuss your project further and collaborate on this exciting opportunity. Please feel free to reach out so we can chat more about your specific requirements. Best regards
£250 GBP på 7 dage
5,7
5,7

Hey, You are looking for Pessary Prototype to Trial-Ready "Lets Gets Started, I know you have several tempting proposals here, but I guarantee you to be impressed by my work. I have various skills in design, Illustration, Photoshop, Graphic Design, Logo Design and Illustrator. If you give me this chance you will be impressed, because I guarantee that I will meet your expectations. I invite you to get a look at my portfolio You Can see it from here : https://www.freelancer.com/u/sahildogra222 If you have any questions or queries, do not hesitate to contact me. I hope to start working with you. With regards! SAHIL
£250 GBP på 2 dage
5,8
5,8

I am here to bring your product to life. I'm a mechanical engineer with 11 years of experience designing industrial product, furniture product, plastic product and machine, automatic system Experience type: 3D, 2D models, Render, Sheet Metals, Machines and Devices, Industrial Products, Plastic Molds, Plastic Parts Software program: Autodesk Inventor, Solidworks, Autocad , NX-Siemens I am always glad to cooperate, I guarantee quick lead-time, information of the project is always confidential . Your project will be developed with speed and high quality, as well as all the jobs already accomplished. Please send me a message
£500 GBP på 7 dage
5,9
5,9

Hello Sir, I am confident in taking your novel vaginal pessary design from CAD files to a trial-ready prototype. With expertise in 3D modeling, Solidworks, and medical engineering, I will refine the CAD, ensure moldability, select the fabrication process, and deliver prototypes for testing. My experience in class-II devices, especially in silicone, will ensure compliance with ISO 10993 for biocompatibility and quality standards. Upon completion, I will provide a comprehensive technical report for your approval. When can we start this exciting project? How soon would you like to begin the prototype development process?
£250 GBP på 2 dage
5,6
5,6

Hi, there I hope you’re doing well. I’m a Mechanical Engineer with strong experience in SolidWorks, Fusion360, Inventor, product design, 3D modeling, Printing, and manufacturing drawings. I’ve completed many projects as following: • 3D modeling and mechanical design with functions • Detailed engineering drawings and GD&T • Product development from sketches or new concept idea • 3D printing(STL) and Design for manufacturing (STEP) • High qualitied Rendering I can deliver accurate results and fast revisions, and I always maintain clear communication and reliability. I’d be happy to discuss your project details and start immediately. Looking forward to working with you. Best regards
£250 GBP på 3 dage
4,8
4,8

Hi, I have produced initial prototype batches of medical-grade silicone devices from CAD files, including dimensional verification and documentation suitable for early clinical evaluation. I also worked on a Class-II silicone catheter device, guiding the design for manufacturability, selecting rapid-tool molding, and delivering sterile-ready prototypes with full inspection and material certification. I'd love to share my experiences with you. Best regards, Tab
£500 GBP på 7 dage
5,1
5,1

Hi there, Would you like to design and fabricate first-in-human prototypes for your vaginal pessary? I can select or justify a suitable process—LSR casting, rapid-tool injection molding, or similar—and ensure biocompatibility according to ISO 10993. The batch will be ready for bench testing and pilot clinical use. I offer high-quality AutoCAD and architectural services. I specialize in 3D interior and exterior designs, landscape designs, elevation designs, floor plans, CAD drawings, and detailed drawings to help bring your ideas to life. You can view my previous work here: https://www.freelancer.com/portfolio-items/10388238-2d-drawing-autocad-plans https://www.freelancer.com/portfolio-items/10388227-3d-interior-models https://www.freelancer.com/portfolio-items/8610743-3d-exterior-elevations-and-models https://www.freelancer.com/portfolio-items/10408072-modern-3d-bathroom-and-bedroom-render Thanks & Regards, Humayo.
£250 GBP på 2 dage
5,1
5,1

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