Credence Management Corporation. Best-in-class total program management

Transcription

1 Credence Management Corporation Best-in-class total program management

2 About us Credence Management corporation is a Plastics Technical Project Management and execution firm, backed by qualified and experienced professionals, that offers a complete range of customized technical support for development of plastics medical devices and healthcare products. Over 60 years of combined experience, we provide a wide range of knowledge based solutions for medical device manufacturing. One of our key competencies is to take an idea through concept to engineering drawing, prototypes, validation, tool design and manufacture of final components and assemblies. From conception to completion, our experts can work together with your team, step by step, and deliver total plastic product solutions with, Reduced time to market Optimized cost Reduced risk

3 What we do? We become your technical resource at demand, and are available at your service to provide equitable assistance for development of Plastics Medical Devices and Healthcare Products. We act as your representative for the project to provide inputs, evaluate data and offer solutions for the product design, Mould Mfg. and Operational Process within given time frame with application of knowledge, skills, tools and advanced techniques. We derive process specifications through Scientific evaluations, to procure parts and assemblies of consistent quality We facilitate the process of project portfolio managements by identifying, prioritizing, and authorizing resources.

4 What we do? We monitor and manage customers projects to ease achievement of their strategic business objectives. We identify and define the challenges and opportunities specific to customer s project that helps team to work smarter and efficiently move forward. We do take responsibility of accomplishing continual and efficient output of the project by providing uninterrupted service throughout the product/project life cycle.

5 Why Credence? An analytical approach to Plastics Medical device and Plastics healthcare product development An established scientific method of qualifying Medical designs, tools and processes A reliable associates for quality, on time delivery & Optimized cost solutions An experienced team in development of Drug Delivery devices, DPI Devices, Plastic components for Medical Devices, & Healthcare segments.

6 Core Competency Program Management Product Design & Development Material Solutions Mold Development & Validation Process Development & Validation Scientific Molding, Cleanroom Molding Value added services & Assembly Industrialization & Automation

7 Core Competency IQ,OQ, PQ Quality Assurance Supply Chain Management Continual Improvement

8 Other Services Good Manufacturing Practices FDA & Regulatory Patent Search Product Testing & Validation

9 Our Services Product Development One of our strength is to take an idea through concept to engineering drawing, prototypes, validation, tool design and manufacture of final components and assemblies. o Concept Creation o Prototype Product (SLAs) o Material Selection o DFM, DFMEA, DQ o DOEs, Reliability & risk Analysis o Mould design, Mould Flow Analysis o Mould development and Validation o Moulding Process Design o Automation Design o Gauge Design & Development o Packaging Design Assistance

10 Concept to Industrialization Phase : 0 Product Definition Phase : 1 Development to Production Phase : 2 Data Transfer Phase : 3 Manufacturing Product Development Customer Voice Concept Development Detail Design, DFMEA, Verification Proto parts, Proto part Verification Final Design, Prod. part Mfg. Drawings, WI, Final Product Specs. Continual Improvement Concept Finalization Proto part Validation Prod. part Validation Technology Development Technical Investigation, Patent Investigation & New IP Generation Technical Detail Design & Refinement File IP Technology Optimization Quality Management Design Requirements Maintain Design History and Records DMR Documents & approvals Implemented QMS Regulatory Support Define regulatory requirements & Develop Regulatory strategy Process Verification & Validation Inputs / Outputs Regulatory submission Regulatory Approval & Certificate Manufacturing DFM Vendor Selection, SCM, Proto & Prod. tooling, Manufacturing process development IQ, OQ, PQ Protocols Mass Production Concept, Rapid Prototype Prototype parts Pre-production parts Approved Production Parts Manufactured Device

11 Our Services Program / Project Management Product Designer Testing & Validation RM Supplier Credence Customer Regulatory Mould maker Manufacturer

12 Our Services Program / Project Management Project Management System is designed to keep our customer on-time, on-budget and informed, from project launch through approval. The system focuses on planning specific milestones for your program and the methods to keep teams, deliverables and costs on track. A dedicated Project Manager is assigned when the business is received. Project Manager ensures effective implementation of project fundamentals to achieve set target. As part of this, the customer regularly receives updated GANTT charts, showing the progress of their program.

13 Our Services Product Design & Development Performance Cost Optimization Manufacturing Life

14 Our Services Product Design & Development One of our strength is to take an idea through concept to engineering drawing, prototypes, validation, tool design and manufacture of final components and assemblies. o Multiple Concept Creation o Prototype Product (SLAs) o Material Selection o Engineering Drawings o DFM o DFMEA o DQ o Tolerance Stack Analysis o DOEs, Reliability & risk Analysis

15 Our Services Product Design & Development We do conduct comprehensive design reviews with our customers and external design agencies at regular intervals, including design & process FMEA's in line with FDA's 21 CFR Early involvement of our team helps ensure optimized design for manufacturability. Working closely with customers from concept design phase, we have been able to optimize the design to achieve, Full functionality, Cost Optimization, Faster time-to-market, Design for manufacturability, Ease of Assembly, Improved Performance, Increase Aesthetics, Intended Product Life Customer Credence

16 Our Services Material Solutions Optimum material for your products. The choice of the right material for a design project can be critical to the success of the product. The selection of the right material can influence design on many levels. Perhaps the most obvious considerations are manufacturing costs and performance of the end product. Here expertise on plastics material comes in picture, o Regulatory compliance for global marketing o Reduced Material Costs o Optimum Product Performance FDA DMF REACh RoHS

17 Our Services Mold / Tooling Development & Validation We understand that highly featured, tight tolerance parts, with aggressive lead times, require top quality mould from the first production run through the life of product. Our technical staff with expertise in moulding, mould development, product development, and materials, enhances success of mould development program with valuable inputs at design stage. Mould Design, Mould flow analysis Mould Development & Validation We offer flexible options of outsourcing Moulds through our partnerships with quality tool shops both in the country and offshore. Our valued tooling partners have been building the most complex, precision molds since last 35 years.

18 Our Services Mold/Tooling Development & Validation The range of tooling we offer includes, Proto Molds Single and Multi cavity production Molds o Expandable and Interchangeable Molds o Stripper and Floating Cavity Plate Molds o Hot Runner System Molds, Conventional and Insulated Runner Molds o Shuttle and Insert Molds, Cartridge Molds, Unscrewing Molds o Mechanical and Hydraulic Core pull Molds o Stack Molds, Over molding Molds Using different material like but not limited to, o Aluminum (proto molds) o Variety of Soft Steel and Pre-Hard Steel Materials o Variety of Hardened Tool Steels, Beryllium Inserts Including finishing operations like, o Specialized Tool Coatings o Surface texturing, Mirror like Polishing

19 Our Services Mold/Tooling Development & Validation Scientific mould validation for consistent product quality throughout mould life The purpose of the validation is to identify a capable mould-process combination, which will achieve required part dimensions and tolerances consistently and repeatedly. A mould-processing window is set during qualification to assure the quality of parts before they are actually manufactured and supplied to the customer. We provide a complete qualification report with the mold manual outlining process and installation parameters. Main steps of process validation are, o Process stability test o Mould viscosity test o Balance of fill Analysis o Gate seal test o Multi cavity analysis o Process capability study (SPC) o Process centring

20 Our Services Injection Molding Services Scientific Moulding in Clean room (ISO 8) for life saving medical devices. We offer flexible options of outsourcing precision plastics components through our partnership programs with cgmp compliance moulding shops for medical products. Scientific injection molding is a strong tool supporting the objectives and practices of a lean manufacturing culture. This benefits our customers in, o Cycle times optimization and thus arriving best manufacturing cost, o Improvement of machine efficiencies and thus increase in productivity. o Reduction or elimination of many forms of waste by robust molding process.

21 Our Services Value Added Services and Assembly We also offer a wide variety of value added services that can save you time and money. Our manufacturing and contract capabilities include, Prototyping Laser Etching Hot Stamping Pad Printing Screen Printing Solvent Bonding Gamma Sterilization contracts Blister Packaging Static Elimination Product Testing contracts Ultrasonic Welding Assembly We are also offering services for Assembly. Depending on the project requirements, it may be fully automatic or semi automatic or Manual with online quality checks and auto rejection of out of tolerance product.

22 Our Services Automation A complete concept creation to up and running of Automation to handle online dimension check, Ultrasonic welding and testing for targeted output. Automation concept, planning and execution for online assembly of moulded parts from multiple injection moulding machine. Automation for Pad printing line, to adopt different variants. Automation for Sprue handling and online grinding and reuse of the same. Automation for complex assembly of medical devices

23 Our Services Process Validation (IQ,OQ,PQ) I n p u t s Design Parameters IQ o o Confirms Installed equipments, peripherals and auxiliary are capable to contribute achieving set targets. Help providing data for equipment status and trend to predict affect on the quality and consistency. O u t p u t s Validated Process Design Specifications Process Development Procedures OQ o o o o List of Installed equipments written for critical processing and systems Outlines the information required to provide evidence that all component of a system operate as specified. Provide a listing of SOPs for operation, maintenance and calibration Define the specification and acceptance criteria Validated Product Process Control Documentations Protocols PQ o o Establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements. Establishing documented evidence through appropriate testing that the finished product produced by a specified process(es) meets all release requirements for functionality and safety. Specifications

24 Other Services ISO : & Device Regulatory compliance support We ensure ISO 13485, FDA and other Regulatory Compliance as Compliance makes good Business sense We will work with your team to full regulatory clearance. cgmp Compliance Support The Good Manufacturing Practice (GMP) requirements are defined in 21 CFR 820. The GMP is also referred to as the Quality System (QS) Regulation. A quality system is required for the design, manufacture, packaging, labelling, storage, installation, and servicing of finished medical devices

25 Other Services Patent Research Support o o Before new idea is put through manufacturing, you need to know if somebody had already discovered it before and had a patent. You can do a patents search through various sources. Doing a patents search helps you know who owns a certain inventions or idea. Product Testing & validation : 3 rd Party The Good Manufacturing Practice (GMP) requirements are defined in 21 CFR 820. The GMP is also referred to as the Quality System (QS) Regulation. A quality system is required for the design, manufacture, packaging, labelling, storage, installation, and servicing of finished medical devices

26 Team s Experience Insulin Delivery Devices First Insulin pen with all plastics parts Healthcare Equipment Healthcare equipment components Injectable Delivery Devices Complex H delivery device Respiratory Care Devices A complete design and development of DPI device

27 Team s Experience Compliance Packaging Child Resistance Blister packing Injectable Devices Injectable Protein Delivery Device Healthcare Device Programmable Human Hearing aid Respiratory Care Device RE &DFM for DPI device

28 Contact us Corporate Office : 311, Atlantis, Sarabhai Campus, Vadodara Gujarat, INDIA. You can reach us through, spatel@credencemgt.com Phone: Mobile :