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RPWORLD Solution for Medical Device

RPWORLD is a leading mechanical part manufacturing supplier. We produce low- to mid-volume parts, and end-use production parts for automotive parts, medical device, biotech research and more industries. Focusing on CNC Machining, Injection Molding, Vacuum Casting and more, we deliver customized mechanical parts in as fast as 3 days. Our manufacturing service helps accelerate products to market, reduce development and production costs, and minimize risk throughout the product life cycle.

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RPWORLD Solution for Medical Device

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  1. Inspiring Innovation Delivering Excellence INNORAPID LIMITED Facilities in Zhongshan: F1-4, Bldg. A1, Henghuifeng Industrial Zone, DaChong Town, Zhongshan, Guangdong Prov., 528476, P. R. China RPWORLD One-Stop Mechanical Parts Manufacturing Solution T: +86 (0) 731 8983 2400 E: info@rpworld.com http://www.rpworld.com

  2. 01 WHO WE ARE P01-08 CONTENTS 02 WHAT WE DO P09-30 CONFIDENTIALITY All the information and documents we received during the cooperation will be treated with complete confidentiality. We will sign an NDA at your request to ensure the 03 WHY RPWORLD P31-54 confidentiality of the information. 04 HOW TO COOPERATE WITH US P55-56

  3. About Us Our Locations and Representatives INNORAPID LIMITED, with brand RPWORLD, offers high-mix, low-volume mechanical parts manufacturing service to global R&D based companies. Canada USA Italy Belgium With 20+ years manufacturing experience accumulation from more than 30,000 projects and continuous innovation of manufacturing technology, we are deeply cultivated in mechanical parts manufacturing for different applications in medical devices, scientific instruments, automotive, aerospace, etc. Specialized in CNC machining, urethane casting, injection molding and sheet metal fabrication along with DFM service, we are dedicated to provide a one-stop customized manufacturing solution and accelerate global R&D based companies' new product development from prototype to mass production. RPWORLD Headquarter WHO WE ARE RPWORLD Sales & Engineering RPWORLD Factory 01 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 02

  4. Milestone 20 years of dedication and commitment. In 2003, INNORAPID LIMITED was In 2005, RPWORLD was added into Thermo In 2020, RPWORLD supported the urgent In 2019, RPWORLD was founded and the brand RPWORLD Fisher USA vendor list and became a reliable production for many medical devices and related certificated “National was established accordingly. production partner for Thermo Fisher USA, companies to fight against the Covid-19. High-Tech Enterprise" . Germany, Switzerland and China. 2003 2003 2005 2016 2019 2003 2020 2024 In 2016, RPWORLD has become a one-stop In 2024, RPWORLD expanded its manufacturing mechanical engineering consulting and capacity to 25,000 square meters, equipped with 70+ production service provider. CNC machines for enhanced production efficiency. 03 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 04

  5. Our Factory 05 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 06

  6. Our Achievements Our Core Values Under Promise, Over Deliver 20+ years experience Medical device 40+ countries supplied  Scientific instrument Renewable Energy 3,000+ active customers 30,000+ Automotive projects completed Industrial automation Aerospace 07 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 08

  7. WHAT WE DO Product Development Milestone Our Services STRATEFY&PLANNING RESEARCH & DEFINITION DEVELOPMENT PRE-PRODUCTION REALIZATION User Needs Design Inputs Design & Engineering Product Documentation Design Transfer Technology Research Design Outputs Prototype Builds Production Ramp Rapid Prototyping Pre- Manufacturing Support Design Verification Project Planning System Architecture Market Launch Design Finalization Risk & Feasibility Proof of Concept Validation/Testing Regulatory Engineering Prototype Mockup On-demand Production On-demand Production Rapid Prototyping 09 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 10

  8. One-Stop Solution for Whole Product Development Cycle Our Processing Technologies ● Look & feel verification ● Structure verification Rapid Prototyping ● Assembly verification Urethane Casting ● Material verification Injection CNC Molding Machining 3D Printing ● Market Testing Sheet Metal Fabrication On-demand Production Extrusion ● End Product Die Casting 11 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 12

  9. Our Processing Technologies Post-treatment, Markings and Versatile Surface Treatments Typical quantities Maximum size Lead time CNC Machining 1-3000 pcs 1600x1100 x500mm 3-20 days Typical quantities Maximum size Lead time Sandblasting Anodizing Brushing Passivation Injection Molding 50-100,000 pcs 610x610x510 mm 1-7 weeks Typical quantities Maximum size Lead time Vacuum Casting Plating Powder coating Painting EMC painting 15-200 pcs 2400x1600 x1200mm 7-15 days Typical quantities Lead time Maximum size Sheet Metal Fabrication 1-1000 pcs 3-15 days 2200x1800 mm Transparency Silk printing Pad printing Laser marking 13 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 14

  10. Mockup Engineering Prototype / On-demand Production 3D Printing (SLA/MJF/SLS) ● As fast as 3 days. ● Better precision in structure. Advantages ● The material is brittle. ● Grainy surface. ● Uncontrollable warpage when Disadvantages printing large dimension parts. ● Low cost solution. RPWORLD Superiority ● Proof-of-concept. ● Structure verification. ● Assembly verification. Application Application Product Info. Client Info. Order Volume Lead Time Process Assembly verification Bio-inactivation device Medical company 1 set 1 week SLA + painting 15 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 16

  11. Mockup Engineering Prototype / On-demand Production CNC Milling/Turning ● Good precision. ● High quality. Advantages ● Relatively high cost per unit. Disadvantages ● Automated manufacturing. RPWORLD Superiority ● Production consistency. Look&feel verification Hair removal device Design company 2 sets 2 weeks CNC + painting + pad printing Application Product Info. Client Info. Order Volume Lead Time Process ● Look & feel verification. ● Structure verification. ● Assembly verification. Application ● Material verification. ● End product. 17 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 18

  12. Engineering Prototype On-demand Production On-demand Production / Engineering Prototype Mockup Mockup Engineering prototype Anesthesia machine Medical company 20 sets 3 weeks CNC Application Product Info. Client Info. Order Volume Lead Time Process End product Precision laboratory equipment for preclinical pulmonary research Application Product Info. Precision laboratory equipment company Client Info. Order Volume Lead Time Process 100 sets/year 4 weeks CNC + black anodizing 19 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 20

  13. On-demand Production / Engineering Prototype Mockup Urethane Casting ● Flexible design. ● Available in a choice of colors. Advantages ● Low start-up cost. ● High similarity to the real product. ● Limited materials. ● Relatively low precision. Disadvantages ● Short lead time. RPWORLD Superiority (As fast as 2 weeks.) ● Market testing. ● End product. Application End product Radiotherapy device Medical company 500 sets 6 weeks CNC+ anodizing with colors Application Product Info. Client Info. Order Volume Lead Time Process 21 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 22

  14. Engineering Prototype On-demand Production On-demand Production / Engineering Prototype Mockup Mockup End product Ophthalmic diagnostic device Medical device company 150 sets/year 4 weeks Urethane casting + rapid tooling + CNC + EMC painting Application Product Info. Client Info. Order Volume Lead Time Market testing Biochemical analysis equipment Well-known medical company 30 sets 3 weeks Urethane casting + CNC machining Application Product Info. Client Info. Order Volume Lead Time Process Process 23 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 24

  15. On-demand Production / Engineering Prototype Mockup Injection Molding End product Robots Ross Robotics robot platform 50 sets/year 5 weeks Urethane casting + CNC machining Application Product Info. Client Info. Order Volume Lead Time ● Low unit price. Advantages Process ● High start-up cost. Disadvantages ● Small batch order is available. ● Relatively short lead time(5-6 weeks). RPWORLD Superiority ● Rapid tooling. ● Material verification. ● Industrialization verification. Application ● End product. 25 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 26

  16. Engineering Prototype On-demand Production On-demand Production / Engineering Prototype Mockup Mockup Market lunch Beauty product A famous beauty production company 100 sets 5 weeks Tooling trials Application Product Info. Client Info. Order Volume Lead Time Process Application Product Info. Client Info. Order Volume Lead Time Process End product Ophthalmic diagnostic device Medical company 1000 sets/year 8 weeks Injection Molding 27 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 28

  17. Outsourcing Manufacturing Capabilities Mass Production The automated system is equipped which is capable of supporting the mass production ( over 100,000 pcs). ● SLA, MJF and SLS. 3D printing ● Bending, punching, laser cutting, welding and surface treatment in one stop. Sheet metal fabrication ● Post-processing of die castings: CNC machining and surface Die casting treatment (painting, powder coating, etc.) ● Post-processing of extruded parts: CNC machining and surface treatment (powder coating, anodizing, etc.) Extrusion ● Supply chain integration and pre-assembly solution. Others 29 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 30

  18. Pain Points of Customers with High-Mix Low-Volume Requirement WHY RPWORLD High-Mix, Low-Volume High Requirements Customer needs are usually a large variety of parts made by Customers, especially some customers from specific industries multiple manufacturing processes and in different materials. like scientific instruments, medical devices, optical instruments, etc. still have quite high requirements for product quality. Flexible Manufacturing Reasonable Cost Flexible manufacturing is required to adapt to changes in the type Reasonable production cost is always a concern for customers. and quantity of the product according to customers demand. Stable Quality Material Traceability Consistency of production is hard to achieve due to the For HMLV requirement customers, it is necessary to have the characteristics of HMLV manufacturing. parts and materials traced and identified so as to prove to their customers and relative regulators that the parts have been manufactured according to industry norms and relevant codes. 31 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 32

  19. Six Reasons to Choose RPWORLD 01 Convenient One-Stop Service Rapid prototyping Mass production From concept to real product, we could make your design come true. From small to large, we could offer you customized production service. Convenient Project Status Update One-Stop Service One-stop solution You only need to communi- cate with one supplier. DFMA Service Strict Quality Control System Excellent Risk Control and Project Management Long-Term Cooperation Reliable material sources Multiple processing technologies Various post-processing and surface treatment Purchasing from the authorized agent of the original material suppliers or directly from the original supplier abroad. 3D printing, CNC machining, urethane casting and injection molding. Various post-processing and surface treatment to meet your functional and aesthetic requirement. 33 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 34

  20. 02 Strict Quality Control System ● Professional quality control specialists and strict Meeting Regulatory Compliance and Standards Requirements Document Archiving quality control management. ● Quality control plan at project review stage. ● Quality traceability from raw material to delivery, COA report, FAI report, In-Process quality inspection report and Final Product Inspection report could be provided. Order Confirmation Project Review (QE, PE,PMC, PD) Quality Control Plan (QE) Quality Inspection Standard (QE) Incoming Quality Control (IQC) Batch Manufacturing Record Production Customer Complaint Handling Delivery Out-going Quality Control (OQC) Final Quality Control (FQC) In-Process Quality Control (IPQC) First Article Inspection (IPQC) Project Closure 35 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 36

  21. 02 Strict Quality Control System Raw material inspection ● X-ray fluorescence (XRF) analyzer ● Infrared Carbon & Sulfur Analyzer ● Material grade identification ● Coating thickness measurement ● Materials compliance(ROHS, REACH, FDA, etc.) Image Dimension Measurement System Handheld XRF Scanner Product quality inspection ● Flash Measuring Machine ● Coordinate Measuring Machine ● Automatic Image Measuring Instrument Laser Handheld 3D Scanner Infrared C & S Determinator Blue Light 3D Scanner 37 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 38

  22. 02 Strict Quality Control System 02 Strict Quality Control System CMM +平均 -平均 名称 最小 最大 平均 标准偏差 离散 RMS Quadratic Element Image Measuring Instrument CMP3 -0.073 0.051 -0.005 0.04 0.04 0.002 0.026 -0.045 参考位置 测试位置 名称 结果名称 公差 偏差 X Y Z X Y Z Comprehensive and Professional Quality Inspection Report Roughness and Profile 结果数据 - 1 CMP3: 1 ±0.1 0.009 7 2.942 8 7.001 2.949 7.995 结果数据 - 1 CMP3: 2 ±0.1 0.008 5 4.568 10 5.002 4.575 9.997 结果数据 - 1 CMP3: 3 ±0.1 0.049 3 6.374 14 2.988 6.416 13.978 结果数据 - 1 CMP3: 4 ±0.1 -0.031 4.396 5 7 4.369 4.989 6.99 结果数据 - 1 CMP3: 5 ±0.1 -0.038 2.667 6 10 2.641 5.975 9.99 结果数据 - 1 CMP3: 6 ±0.1 -0.071 -0.178 7 13 -0.217 6.95 12.968 Flash Measuring Machine Inspection Report 39 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 40

  23. 02 Strict Quality Control System 03 Excellent Risk Control and Project Management On Time, On Budget, Keep Promise, Exceed Expectations ISO 14001:2015 Certificate Calibration Certificates ISO 9001:2015 Certificate CAM 2 days CNC Milling 7 days Color & texture sample confirmed 3 days Assembly testing 2 days After-treatment 5 days Pre-assembly & QC 3 days Products delivery 3 days ISO 13485:2016 Certificate AS 9100:2018 Certificate Calibration Certificates Certificate of Approval This is to certify that the Quality Management System of: INNORAPID LIMITED F1-4, BUILDING A1, HENGHUIFENG INDUSTRIAL ZONE, DACHONG TOWN, ZHONGSHAN CITY, GUANGDONG PROVINCE, P. R. CHINA has been audited in accordance with the requirements of EN 9104-001:2013 by Bureau Veritas Certification and conforms to the following Quality Management Systems Standards detailed below Standards BS EN ISO 9001:2015 EN 9100 : 2018 (Technically equivalent to AS9100D) Scope of certification Day 23 Day 1 CUSTOM MANUFACTURING SERVICES FOR AEROSPACE APPLICATIONS, INCLUDING CNC MACHINING, PAINTING AND POWDER COATING. Certification Structure: Single Site This certificate forms part of the approval identified by certificate number: 06-03-2025 CN054017 Original ASCS Approval: Certificate Issue Date: Certificate Expiry Date: 06-03-2025 05-03-2028 Project Assessment Products Delivery Trevor William Douce Authorised Signatory Further clarifications regarding the scope of this certificate and the applicability of the management system requirements may be obtained by consulting the organisation. Certification Body: 5th Floor, 100 Lower Thames Street, London, EC3R 6DL, United Kingdom 1/1 41 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 42

  24. 04 Project Status Update Production schedule Standard Packaging W31 W32 W33 W34 26 27 28 29 30 31 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 CAM CNC Milling Color & texture sample confirmed Custom Assembly testing Packaging After-treatment Pre-assembly & QC Products delivery Remark Shipping R Method Planning Actual progress Products/samples delivery Products/samples arrived Selection 43 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 44

  25. 05 DFMA Service Project background: ● The original design is too thick in some area of the housing wall which will lead to shrinkage. DFM solution: ● We suggest optimizing the design following the principles of injection molding production by adding draft angle and uniforming the wall thickness. Result: ● The customer is satified with the quality of the injection molded parts and we have been supporting the production of this project for 2 years and each year 5000 pcs. 45 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 46

  26. 05 DFMA Service Original Proposal Original Proposal Risk: Shrinkage marks RPWORLD Proposal: We suggest adding 2x grooves on core side to weaken the defect. Risk: Potential assembling issue RPWORLD Proposal: We suggest increasing length of the part, so it can be located in bottom hole easily. Original Proposal Original Proposal Risk: Mold kiss-off structure is easy to break RPWORLD Proposal: We suggest adding 3° draft angle as showed above to weaken the defect. Risk: Potential assembling issue RPWORLD Proposal: We suggest adding fillet on edge of bottom hole, thus spring is easier to push inside. 47 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 48

  27. 06 Long-Term Cooperation 06 Long-Term Cooperation 20+ years 95% 85% 32% Customer  Customer Repurchase Rate Annual Sales Growth Footprints Recommendation Rate 49 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 50

  28. 06 Long-Term Cooperation We have been working with RPWORLD since Few surprises about lead-times, quality and results are very consistent. Innorapid Limited was rated 100 points 2009. This continuity means that there is a in supplier evaluation of Thermo Fisher Scientific. two-way understanding of how both companies Turn around of projects is very fast and few technical challenges are operate, both at the technology level and at the considered impossible. organizational level, therefore few surprises about lead-times, quality and results are very This is crucial for a small, innovative technology company. consistent. Turn around of projects is very fast and few technical challenges are considered Subject: Thermo Fisher Supplier evaluation 01.10.2021 to 30.09.2022-1009322-INNORAPID LIMITED impossible. This is crucial for a small, innovative technology company. RPWORLD has itself Dear Ladies and Gentleman, Thermo Fisher Scientific strives to provide its customers with the best products and services possible. In order to achieve this goal we have to depend on each supplier's quality and delivery performance. To ensure this we have implemented a supplier performance measurement process, because only with continious improvement of the delivery quality can we expand our existing business. grown and changed in these nine years and now has the ability to scale production (for example tool-making and plastics injection) as require- ments evolve. This is a valuable factor when planning future development work. Below are your results of the evaluation: Supplier Number: 1009322 Supplier Name: INNORAPID LIMITED Your Performance Rating: 100 A-Supplier: 80 to 100 Points B-Supplier: 60 to 79.9 Points C-Supplier: 0 to 59.9 Points Your SOTD (12 Months): -100% in Points: 25 Your DPPM (12 Months): -1 in Points: 25 Customer Support (12 Months) in Points: 50 Mr. Norman Co-Founder Ross Robotics 51 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 52

  29. 06 Long-Term Cooperation Quality Very Responsive Highly Professional Trusted Partners Innorapid is very responsive to I would like to take a few minutes to thank you Please be assured I often talk about the The mockups were executed with a evolving needs. Many new projects come with and RP World’s team for your support in quality of products we got from Innorapid. high-level of care, and the interaction with tight deadlines, but they are always able to resolving prototype issues for the latest We got many CNC machined plastic your team was highly professional, with your work within our timelines to deliver quality parts aluminum parts. components from your company and were manufacturing and design team very on schedule. They really follow their motto This is in those situations that we can see the very pleased of the result. proactive in proposing solutions and Under promise, over deliver and are definitely a value of professionals and a trusted partners clarifying details. good partner! like RPWORLD. From Purchasing Manager of an optical instrument company From Senior Mechanical Engineer of a From Mechanical Engineering Manager of a From the President of a large design firm well-known medical device company scientific instrument company 53 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 54

  30. HOW TO COOPERATE WITH US Innorapid Limited 中山英诺莱比智能科技有限公司 Quote prepared and DFM service 3D CAD sent PO confirmation Part manufactured Part inspected Part shipped Signing NDA and sending your Our project manager will analyse Our project manager will After confirmation of the PO, Part inspected according to Part will be custom packaged 2D and 3D drawings to your your demand and come back to you confirm receipt of the order. the production is released. your drawings and inspection and shipped once you contacts. with the quotation and DFM report. report could be provided. confirmed. 55 RPWORLD® is a registered trademark owned by INNORAPID LIMITED. 56

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