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Adult Urology Resectoscope Set 26.5fr Outer Sheath Customized Request

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Province/State:zhejiang
Country/Region:china
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Adult Urology Resectoscope Set 26.5fr Outer Sheath Customized Request

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Model NO. :HA3165.3S
OEM :Acceptable
ODM :Acceptable
Transport Package :Standard Export Packing
Specification :26.5Fr
Trademark :Vanhur
Origin :Tonglu, Zhejiang, China
HS Code :9018909919
Supply Ability :200 PCS/Month
Type :Sheath
Application :Urology
Material :Steel
Feature :Reusable
Certification :CE, FDA, ISO13485
Group :Adult
Customization :Available | Customized Request
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Customization Adult Urology Resectoscope Set 26.5fr Outer Sheath Customized Request

1 Introduction:
If you are looking for minimally invasive surgery medical instruments with good quality, competitive price and reliable service. Wanhe medical is manufaturing these for you. We provide general and professional laparoscopic instruments with CE, FDA approved.

2 Specifications
Adopt 3Cr13, 304, 630 stainless steel material
Tough construction
Corrosion resistant
High durability
Safety application

Adult Urology Resectoscope Set 26.5fr Outer Sheath Customized RequestAdult Urology Resectoscope Set 26.5fr Outer Sheath Customized RequestAdult Urology Resectoscope Set 26.5fr Outer Sheath Customized Request


Adult Urology Resectoscope Set 26.5fr Outer Sheath Customized Request
Adult Urology Resectoscope Set 26.5fr Outer Sheath Customized Request

3 Packing & Shipping:
Package detail: Poly bag and special shockproof paper box.
Delivery detail: By air

FAQ


Key factors of quality control in medical device production

In medical device production, quality control is a key factor to ensure that products are safe, effective and compliant. The following is a detailed release on the key factors of quality control in medical device production:

Raw material selection and control:

Select high-quality raw materials that meet standards to ensure product reliability and safety.

Establish a cooperative relationship with reliable suppliers, conduct supply chain quality management, and ensure the traceability and stability of raw materials.

Production process control:

Accurately locate the key nodes in the manufacturing process, clarify the key processes, and establish a complete monitoring system.

Implement standardized operating procedures to ensure that each step is carried out in accordance with regulations.

Use advanced monitoring technology and equipment to comprehensively and continuously monitor key processes to achieve full control.

Emphasis on training and assessment of personnel to improve their operating skills and ensure the accuracy and stability of each link.

Quality management system:

Establish a standardized quality management system, such as ISO 13485, which is an internationally recognized quality management system standard for the medical device industry.

Regularly evaluate and continuously improve the quality management system to ensure its effective operation.
The management representative needs to be familiar with relevant laws and regulations and quality management system requirements, and is responsible for establishing and maintaining the quality management system.
Supplier management:

Establish a supplier audit system, sign quality agreements with major raw material suppliers, and clarify the responsibilities of both parties.
Select and manage suppliers, review them from the perspective of supply chain management, ensure that they have the ability to continuously improve and establish a sound communication mechanism.
Product quality testing and monitoring:

Accurate quality testing and monitoring are important means to ensure product quality, including regulations on sampling containers, raw material purchases, in and out of warehouse management, production operation specifications, etc.
Strictly manage rework control of non-conforming products, adverse event monitoring and analysis, corrective measures and preventive measures, product information notification procedures, and internal audits of the quality management system.
Continuous improvement mechanism:

The continuous improvement mechanism is an important means to ensure continuous improvement of product quality, including analysis of medical accident reports, taking corrective measures to protect customers from non-compliant products, and eliminating the root causes of problems.
Develop and document risk management requirements. When changes may affect the safety or effectiveness of medical devices, risks should be assessed and measures should be taken to reduce risks.
Through the comprehensive management and control of the above key factors, the quality level of medical devices can be effectively improved to ensure the safety and health of patients. These measures not only cover the entire production process from raw material selection to final product release, but also emphasize the importance of continuous improvement and comprehensive quality management.


What are the best practices for raw material selection and control in medical device production?


In medical device production, the best practices for raw material selection and control include the following aspects:

Certification system: Many countries and regions have established certification systems, such as CE certification and FDA certification, to ensure the quality and reliability of medical device raw materials.

Selection principle: Select materials with good compatibility with human tissues to reduce rejection and inflammation. At the same time, consider the biological stability of the material to ensure that it will not change or degrade during long-term use in the human body.

Preliminary inspection: Perform appearance and size inspection on the raw materials to preliminarily determine whether they meet the requirements, and record the inspection results in detail and issue an inspection report. For unqualified raw materials, the supplier must be notified in a timely manner and appropriate treatment measures must be taken.

Batch management and traceability: Implement batch management, establish a complete record of raw material use, and ensure the traceability of product quality.

Comprehensive assessment: Manufacturers must conduct a comprehensive selection and assessment of raw materials to ensure their compliance and safety. This includes a comprehensive inspection of the chemical properties, physical properties, etc. provided by the raw materials.

Quality standards: Clarify the main indicators of raw materials and formulate scientific and reasonable quality standards as the basis for acceptance.

Supplier management: Select qualified suppliers, purchase raw materials that meet quality requirements, and conduct strict evaluation and management of suppliers.


How to establish and maintain a quality management system that complies with ISO 13485 standards?


Establishing and maintaining a quality management system that complies with ISO 13485 standards requires following a series of detailed steps and principles. The following are specific methods:

Preliminary preparation stage
Understand the standard: First, study and understand the requirements and content of ISO 13485 standards to ensure a basic understanding of the standard.
Leadership decision-making: The establishment of a quality management system requires the support and decision-making of the top management, especially the leadership to recognize its importance.
Planning stage
Establish a team: Form a dedicated team to be responsible for the establishment and implementation of the quality management system.
Documentation: Develop a detailed document system, including quality manuals, procedure documents, work instructions, etc., to ensure that all processes have clear written records.
Implementation phase
Internal implementation: Implement the requirements of the quality management system step by step according to the plan to ensure that each link complies with the ISO 13485 standard.
Monitoring and measurement: Obtain relevant data of products and processes in a timely manner, evaluate quality performance, and take necessary corrective measures by establishing monitoring and measurement activities.
Audit and review phase
Internal audit: Conduct internal audits regularly to check the operation of the quality management system, identify and solve existing problems.
Management review: The top management will preside over the management review meeting to evaluate the effectiveness and suitability of the quality management system and make necessary adjustments and improvements.
Continuous improvement
Continuous improvement: Improve operational efficiency and resource utilization through continuous optimization and improvement of processes to achieve continuous improvement of the quality management system.
Certification application
Submit documents and information: Prepare and submit various documents and information to apply for ISO 13485 certification.
Certification audit: Accept the audit of external certification bodies to ensure that the quality management system meets the requirements of ISO 13485 standards.
Regulatory compliance
Regulatory compliance: Identify and determine the compliance with relevant regulatory requirements to ensure that the quality management system meets the regulatory requirements of the country or region.



Which advanced monitoring technologies and equipment are most effective in the production of medical devices?


In the production of medical devices, advanced monitoring technologies and equipment are essential to improve medical quality and patient safety. The following technologies and equipment are considered to be the most effective at present:

PET-CT equipment: PET-CT is an integrated and perfect fusion of the functions of high-end PET scanners and advanced spiral CT equipment, mainly used for early detection and diagnosis of major diseases such as tumors, brain and heart.

Pulsed field ablation (PFA) technology: This new innovative medical device occupies a prominent position in diabetes treatment, especially in medical news at the end of 2023 and the beginning of 2024.

ePM series patient monitors: ePM 10M/ePM 12M patient monitors have a variety of monitoring parameters, such as ECG, blood oxygen, blood pressure, etc., and support dynamic EWS (early warning score), ERAS assistant, GCS Glasgow Coma Score and other intelligent auxiliary applications, which can meet clinical monitoring needs.

Wearable sensors and trunk network technology: These new low-power, highly sensitive physiological parameter indicator biosensors and high-performance universal monitoring technologies and equipment are suitable for health monitoring and intervention for individuals, families, communities and hospitals.

Piezoresistive force sensors: TE's micro-melting force sensors are used in medical devices such as infusion pumps to ensure the smooth flow of fluids by monitoring the blockage of infusion tubes, thereby improving patient safety and treatment effects.

Magnetic resonance imaging system (5T): uMR Jupiter 5T is the world's first 5.0T human whole-body magnetic resonance system with breakthrough performance, enabling more accurate imaging diagnosis.

Surgical robots: High-end equipment such as the da Vinci surgical robot and the Noli Knife radiotherapy system are widely used in complex surgeries and precision treatments, improving the success rate of surgery and patient prognosis.

These advanced monitoring technologies and equipment not only improve the accuracy of medical diagnosis and treatment, but also greatly enhance the quality and safety of patient care.


What is the role of supplier management in ensuring the quality of medical device products and how to evaluate it?


Supplier management plays a vital role in ensuring the quality of medical device products. Through effective supplier management, it can be ensured that the purchased raw materials, parts and components can meet the quality requirements of producing high-quality products, which directly affects the performance, safety and reliability of the final product.

The role of supplier management
Quality control: Supplier management helps to conduct strict audits and evaluations of suppliers to ensure that the items or services they provide meet the company's quality standards and regulatory requirements.
Risk reduction: By regularly evaluating and monitoring the performance of suppliers, problems that may affect product quality can be discovered and resolved in a timely manner, thereby reducing potential risks.
Continuous improvement: Establishing good communication and cooperation with suppliers can promote cooperation between the two parties in quality improvement and improve overall product quality.
Evaluation method
Historical quality performance: Evaluate the supplier's past product qualification rate, customer complaint rate and other indicators to understand its historical quality performance.
On-site evaluation: Verify whether the supplier has the ability to produce high-quality products through on-site inspections of the supplier's production facilities and operating procedures.
Third-party certification: Refer to whether the supplier has passed the relevant quality management system certification (such as ISO 9001), which can be used as an important indicator of its quality management capabilities.
Questionnaire survey: Collect feedback from other customers through questionnaire surveys to understand the supplier's service quality and delivery capabilities.
Classification management: Classify and manage suppliers according to the degree of impact of purchased items on product quality, and focus on monitoring suppliers of major raw materials and parts that have a greater impact on product quality.
Implementation steps
Establish an audit system: Establish a complete supplier audit system in accordance with the requirements of the "Medical Device Production Quality Management Specifications" and formulate corresponding audit procedures and standards.
Regular evaluation: Conduct regular comprehensive evaluations of suppliers, including supply quality, technical level, delivery capacity and other aspects.
Risk analysis: During the evaluation process, if it is found that the supplier has major defects that may affect the quality of the purchased products, procurement should be stopped and corresponding measures should be taken to reduce risks.
Continuous improvement: Maintain close contact with suppliers, encourage and support them to improve quality, and jointly improve product quality.



What are the implementation strategies of the continuous improvement mechanism in the medical device industry?


In the medical device industry, the implementation strategies of the continuous improvement mechanism mainly include the following aspects:
Medical device companies should establish a sound quality management system to ensure that the quality of medical devices meets relevant requirements through quality risk management, quality verification and validation. The "Medical Device Business Quality Management Standard" also clearly proposes the establishment of a quality system, quality policies and objectives, fulfillment of principal responsibilities, system self-inspection and continuous improvement clauses.

Through data analysis and feedback mechanisms, the overall maintenance of medical equipment is regularly monitored and evaluated, and continuous quality improvement work is carried out. The using departments need to conduct regular self-inspection, summary analysis and rectification of daily maintenance and management; the competent departments need to regularly supervise, inspect, analyze and feedback, and check the implementation of rectification.

The PDCA (Plan-Do-Check-Action) cycle management is implemented for all medical equipment and medical consumables in the hospital. After a cycle, some problems are solved, and there may be unresolved problems or new problems, so as to continuously optimize and improve.

Medical device companies should combine intelligent technology into product portfolios and services, actively influence the treatment process, and interact with patients to improve the overall service quality and efficiency.

Carry out regulatory and professional knowledge training, give play to the functions of social organizations, improve the endogenous motivation and talent reserves of enterprises, so as to better implement the continuous improvement mechanism.

The organization should take necessary corrective measures to eliminate the causes of non-conformity and prevent the recurrence of non-conformity. Prepare documented procedures to define the review of non-conformities, determine the causes of non-conformities, evaluate the need for measures to ensure that non-conformities do not recur, plan and document the required measures, implement measures, and verify the effectiveness of corrective measures.

Establish the concept of continuous improvement, encourage employees to continuously put forward suggestions and opinions for improvement, and form a good corporate culture atmosphere.



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Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
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