Amedcon Healthcare Manufacturing Ltd.

Project Management

Complex tasks are mastered at Amedcon through our Project Management team. For this purpose, we form specialist teams that to plan, organize and process projects with our customers promptly and reliably.

Our project managers are responsible for all project steps from the creation of the functional requirements through the development of prototypes to mass production and are also responsible for the observance of scheduling and budget specifications over the entire period of the project. They visualize the course of the project in detailed project plans and are informed of the status of the project at all times. Problems occurring are in this way detected at an early stage and countermeasures are developed.

We always start with a discussions about a customer’s target and general description of the product. In this first step to share initial specifications, drawings, or engineering files regarding the projects so that we can work to meet the design specifications. We are always more than willing to sign non-disclosure agreements to protect customers’ technology, designs, or other intellectual property.

The establishment of quality starts from the development phase

The quality requirements for medical device increase continuously. With our quality management we rely consistently on "Quality by Design". With this concept, quality is already systematically anchored in the products and processes by our quality and engineering team during the development phases. The Quality Assurance department works together closely with all other involved departments during all phases of the product origin process. Quality by Design is in this way not only the securest, but also the most economical way to bring medical device into the market.

Our project manager will work with all departments of product development under one roof: Program Management, Product and process development, Mold making, Automation Engineering, Product and process development, Quality Planning and Small Batch Production. In this way, we promote the intensive cooperation between Quality Assurance and the other departments to enable gap-free quality management through the entire product origin process, from the idea to the series production-ready product. In the process, we consistently rely on an integrated Quality by Design concept that reduces total costs, shortens the time to market, minimizes coordination work and reduces the risks of the product.

Risk management - identification, evaluation and controlling of risks

Risk management is established at the beginning of the product develop-ment stage

Identify, analyze and evaluate risks that could originate from a product or component

Evaluate the probability of occurrence, the frequency of discovery, and the severity of the risk

Formulate reduction measures for controlling risks.

Through analysis of design FMEA, the risk consideration in the project is also identified for the manufacturing process (injection mold, assembly of the individual parts extending to the finished device), the packaging and potential processes for external service providers or transport.

Process control plan

The process control plan with inspection and testing requirement will be conducted to critical functions which are derived from the results of the design and process FMEA and flow into the test plans. Test plans for the incoming goods test, the in-process inspections and the final approval are thereby created by the person responsible for the quality of the project.

Design and Engineering

Our customers count on us for invaluable early involvement with engineering support. Therefore our experienced engineers would give recommendations as early as from the beginning of customers idea until the final product is done. We would work closely with our customers to get an optimal solution, not only to ensure the performance and functionality of the product meeting customers' requirement, but also to achieve cost effectiveness during mass production run.

Engineering capabilities:

Engineering evaluation with methodology of DFMA (Design for Manufactur ing and Assembling)
Establish device master file for controlling design input and output
Advanced software of 3D modeling (SolidWorks)
Product Simulation and Mold Flow Analysis
Experienced in various medical grade engineering materials
Robotic and Automation design
Packaging Design

Prototype

In order to demonstrate the design feasibility and doing the functional test of a product before tooling fabrication and going to mass production, prototyping is one of the most important stages during the product development process.

We provide the following prototyping services:

Rapid prototyping in SLA and SLS
CNC machining with precise dimension controlling
RTV (Silicone) casting molds to make multi-prototype samples
Available in various choices of materials either in plastic or metal such as ABS, PC, PP, PMMA and Stainless Steel … etc.

Tooling / Mold

Tooling is top priority to determine the quality of an end product. Our multi-cavity production molds are designed for the high output quantities and sophisticated quality requirements of the medical industry. The molds are produced in clean room-compatibly for stainless steel. Needle sealing nozzles exclude the formation of threads and thus of particle formation during demolding. The good ventilation of the molded part in the cavities prevents sedimentations that can also come loose in the form of particles. A glide-promoting coating of all movable parts in the mold ensures that no lubricant needs to be used. Adequate demolding angles ensure clean part demolding and avoid abrasion. Only through the use of high-quality fabricated tooling, which can achieve stability in injection molding, repeatable dimensional accuracy and cost effectiveness.

Our engineers would utilize 3D modeling softwares for mold design and mold flow analysis, thus we could predict potential problems prior to tooling fabrication. While we are equipped with precision CNC or wire-cut machines, we could make the tooling parts directly from the solid model designs by translating tooling geometries to the CNC machining centers and high speed graphite and copper mills for electrode parts. We have full wire EDM capability along with various surface finishing.

We are capable of building different mold standards from small batch production to large quantities mass production.

Class 101 – Up to one million shots for extremely high volume production
Class 102 – Not exceeding one million shot for high volume production
Class 103 or 104 – Between 100,000 – 500,000 shots for medium / low volume production
Class 105 – Under a few thousand shots with single cavity for small batch production or design validation purpose.

Our capabilities are as below:

Single Cavity and Multi Cavities Tooling
Insert Mold Tooling
Hot Runner Tooling

Validation

The thread for all our qualification and validation activities in the project is the Validation Master Plan (VMP). The complete strategy for the qualification and validation of the production equipment, as well as the related processes, for example: injection mold tools, assembly lines, and measuring equipment are defined and documented here. The VMP also encompasses the validation of external processes, for example: sterilisation or other outsourced processes. The VMP is created by the person responsible for the quality of the project in cooperation with the other departments.

Our validation encompasses all phases of IQ up to PQ. Each individual production process is validated in order to ensure that the total of all steps leads to the desired, process-secure production sequence. During the production process, the tests defined in test planning and verified during validation extending from incoming goods through process tests to approval testing are carried out by our quality department in cooperation with production. Our Quality Planning has its own quality lab in which extensive tests in the areas of material, geometry and function are carried out during all phases of the product origin process. It contains a measurement room with product-specific testing equipment for the geometric measurement of components, assembly units and finished products.

Validation will include:

Installation Qualification (IQ) for equipment and machines,
Operational Qualification (OQ) and
Performance Qualification (PQ) for the manufacturing process.

Pilot Run

Accompanying development, initial samples can be manufactured in a small batch production run. All necessary information, for example: test plans and technical drawings will thereby be handed over to the Production department by the Quality Engineering department. The production of sample parts, small series or batches for the product registration are monitored by an employee of Quality Management.