Quality System overview 

  Every company involved in medical devices has established a quality system in accordance with ISO 13485, but the quality of the products they produce varies widely. Why?
  Because the quality control system is really complicated! Good quality products depend on how to understand the true meaning of quality control, what control measures are applied, and to what extent the measures are implemented in all aspects of R&D, production and sales. To avoid abstraction and difficult to understand, I chose our Laparoscopic Hand Instruments(LHI) as a case to show you how our specific quality control measures are implemented. 


  The following figure is a simplified version of the LHI quality control flow chart:

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    The Product Requirements

      Demands collection and requirements analysis requires sufficient patience and perseverance because the process is long and arduous, and the surprise of accidental discovery highlights our day and night research. 
      We searched thousand s of clinical literature and 500 articles are selected and over 200 articles detailed studied, and we gained the expirecence and the inspiration. 
      We searched over 20000 patents and over 3000 patents are downloaded and carefully reading and undstanding, and we have comprehensive grasp of the the prior arts. 
      We collected all the Adverse Event Report of the leading brands of laparoscopic hand instruments and tried to find out the reason of each accident and its possible hazards, and we found the direction of improvement.

  • The Prototyping and Simulation

      We have designed and produced hundreds of prototype devices to simulate and test our needs through clinical research, patent study, and adverse event learning. It was a time consuming difficult task, by doing these experiment we refine our requirements and made over 50 inventions. Let me give you a few examples:
      - We found the root cause of some serious adverse events of major brands, even the brand owners themselves did not know, and we have made corresponding improvements to these issues and applied to our own products. 
    Is this real? 
      Yes, let us show you face to face!


      -The laparoscopic graspers can be divided into 4 types according to their tooth profile, small triangular tooth, large triangular tooth, pyramid tooth and Debakey tooth. In order to study the jaw-tissue interaction, we have designed more than 100 tooth profiles. How is this possible? But it is true, let us show you face to face!


      -We found the old-fashion product's heavy relying on the assembly skills of the workers leads to poor product consistency, so we try to design and manufacture products that do not rely on the skills of the workers, even if the newly graduated students can be assembled with good consistency after simple training. 
    Can this goal be achieved? 
    Of course! We can already provide you with such samples.

  • The Detailed Design

      After determining product specifications and breaking through key technologies, we design, test, verification and validation the instruments comply with highest international standards. There are no mandatory performance standards or special controls in existence for this the 5RMED Laparoscopic Hand Instruments which were designed to meet the following voluntary standards:
      EN 60601-1, EN 60601-1-2, EN 60601-2-2, EN 60601-2-18, Medical electrical equipment, General requirements for basic safety and essential performance;
    ISO 10993-1, ISO 10993-5, ISO 10993-10, Biological evaluation of medical devices;
    ISO 11607-1, EN 868-5, ASTM F 1980-02, ASTM F1929, ASTM F88, relevant test standards for sterile barrier systems;
      ISO 14644, ISO 14698, ISO 11737-1, Cleanrooms, Bio-contamination control;
    ISO 11137-1, ISO 11137-2, EN 556-1, Irradiation sterilization;
    EN 1041, EN 980, ISO 15223-1, ISO 16061, relevant standards for labeling, instruction for use; 
    EN 62366-1, Medical devices — part 1: application of usability engineering to medical devices;
    EN ISO 7153-1:2016, EN ISO13402, EN10088, relevant standards for metals, surgical instruments; 
    ISO 7741-1986, ASTM F1079-87(2014) Standard Specification for Surgical Scissors;
      In addition to testing according to the above international standards, we also carry out the necessary performance tests, including:
      dimensional accuracy testing, 
      material performance testing, 
      ultimate strength testing of working-jaw, 
      heat resistance testing of instrument insulation tubes, 
      consistency of driving force, 
      ergonomics test, 
      simulation test under the simulator, etc.
      Under the condition of signing a confidentiality agreement, we could provide you with relevant test reports.

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  • The raw material supply and parts manufacturing

      Raw materials and the precision machining of parts is very important for the quality of the product. We use raw materials from famous brands such as BASF and Covestro, and we will not use cheap raw materials to reduce our costs. We use design optimization and production division and cooperation to reduce costs. Rely on our R&D strength and take advantage of China's complete and efficient and relatively inexpensive supply chain system, we could supply of abundant innovative precision instruments with affordable price. 
    The following shows several scenarios for the manufacture of parts for 5RMED Laparoscopic Hand Instruments:

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    Manufacturing Grasper-jaw by Metal Injection Molding

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    Inspecting the jaw quality by CCD automatic inspection system

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    Manufacturing Scissor-blade by continuous stamping process

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    Machining the blade with an automatic grinder

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    Manufacturing Driving-link by metal cold extrusion process

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    Manufacturing Driving-rod by turning and milling composite process

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    Manufacturing Insulating-tube by Plastic Extruding

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    Manufacturing Handle-part by Plastic Injection Molding

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    Manufacturing Packaging by Automated sterile barrier bag production line

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    Manufacturing jaw-part by vacuum heat treatment

  • The Clean Room Production Process

      We have a plant area of 3000 square meters. The infrastructure of the company includes: Class 100, 000 clean room,  Class 10,000 microbiological detection room, the total area is 510 square meters. The company has equipped water purification system supplying purified water for final cleaning process.

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