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1 Introduction:
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2 Specifications
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3 Packing & Shipping:

FAQ

Medical device production quality control procedures released

Medical device production quality control procedures have been released. Specific information is as follows:

The purpose of the medical device production quality control procedures is to conduct prescribed inspections and tests on the entire production process to ensure that uninspected and unqualified products are not put into use, processed or shipped.
The production environment should be clean and meet the product quality needs and relevant technical standards. If the product has special requirements, it should ensure that the external environment of the factory does not affect the product quality, and verification should be carried out when necessary.
Enterprises should formulate finished product inspection procedures based on mandatory standards and registered or filed product technical requirements, product delivery requirements, and internal control standards of the enterprise. The finished product inspection procedures should determine the verification/confirmation/monitoring/measurement/inspection/test procedures and requirements for routine control of finished products to ensure that the production process is controlled.
The medical device production quality control procedures have been clearly released, and their content covers all aspects from the production environment to the finished product inspection to ensure that the quality of medical devices meets the requirements of relevant laws and regulations and standards.

What are the specific implementation steps of the medical device production quality control procedures?

According to the results, the specific implementation steps of the medical device production quality control procedure can be summarized from the following aspects:

Enterprise hardware planning and implementation: It is mentioned that medical device manufacturers need to plan and implement factory buildings, facilities and equipment, which is the basis of product quality control. This includes establishing and equipping suitable production sites, environmental conditions and production equipment.

Follow the "Medical Device Production Quality Management Specifications": It points out that enterprises should strengthen the quality control of the entire process of product realization, especially the procurement and production processes, as well as the management of finished product release in accordance with the requirements of the "Medical Device Production Quality Management Specifications" and its appendix issued by the State Food and Drug Administration.

Control procedures in the design and development stage: It emphasizes that enterprises should establish and document design control procedures to plan and control the design and development process of medical devices.

Production process control: It describes the specific steps for the production engineering department to arrange production according to the production plan, including issuing drawings and "Work Order" to the workshop director, and indicating the processing quantity and product number/batch number and other information and working hours on the "Work Order", requiring workers to complete it within the specified working hours.

Internal Audit: It is mentioned that in order to effectively conduct internal audits of medical devices, it is essential to develop a comprehensive audit checklist to ensure that all relevant aspects are covered and to help maintain consistency between audits.

The implementation steps of the medical device production quality control procedure include the planning and implementation of the enterprise hardware, compliance with the "Medical Device Production Quality Management Specifications", control procedures in the design and development stage, production process control, and internal audits.

How to formulate finished product inspection procedures based on mandatory standards and product technical requirements?

The steps to formulate finished product inspection procedures based on mandatory standards and product technical requirements are as follows:

Clarify the mandatory standards: First, the company needs to understand and clarify the applicable mandatory standards. These standards are unified technical requirements in the fields of agriculture, industry, services, and social undertakings, and must be implemented.

Check product technical requirements: The company should check the registered or filed product technical requirements. These requirements include product performance indicators, inspection methods, terminology and appendices. Product technical requirements are the core technical elements of product standards and should be followed by principles such as performance characteristics, verifiability, measurability, feasibility, and verifiability.

Preparation of finished product inspection procedures: According to the mandatory standards and product technical requirements, enterprises shall formulate detailed finished product inspection procedures. The procedures shall at least include the following:

Name, specification and model of finished products
Verification/confirmation/monitoring/measurement/inspection/test items and methods
Applicable instruments and equipment
Sampling procedures and sampling plans
Acceptance criteria
Reference standards/reference measurements
Ensure rationality and operability: When preparing finished product inspection procedures, it is necessary to ensure that they meet the requirements of mandatory standards, and that the performance indicators are reasonable, and that the inspection methods are repeatable and operable.

Quality control and release: Enterprises shall conduct quality control according to the finished product inspection procedures, and release finished products after meeting all requirements.

What are the common quality problems and their solutions in the production process of medical devices?

The common quality problems and their solutions in the production process of medical devices are as follows:

Unstable quality of raw materials:

Solution: Establish a strict raw material inspection mechanism to ensure that all raw materials undergo strict quality inspection and certification before entering the production line.
Handling of defective products during the production process:

Solution: Record, classify, evaluate and handle defective products, including rework, scrapping and other measures. At the same time, establish a complete product traceability system to record key information in the production process so that the cause can be quickly located when problems arise.
Quality control in the packaging process:

Solution: The packaging of medical device products is an important link in the production process, involving multiple process flow points. There may be risks in every transfer and every process flow point. Therefore, strict quality control is required at each link to ensure that the packaging process meets the requirements of the "Medical Device Production Quality Management Specifications".
Insufficient equipment management and data management:

Solution: Use MES system (manufacturing execution system) to cover complete production solutions from medical raw materials to warehouse management, quality inspection, quality management, production management, equipment management, etc. Through software and hardware interface synchronization, data analysis management and electronic kanban management, help enterprises improve quality mechanisms, realize factory visualization, complete traceability of product production processes and archiving of production data.
Management of key processes and special processes:

Solution: The enterprise shall prepare production process procedures, operation instructions, etc., clarify key processes and special processes, and verify or confirm the important parameters of these processes to ensure product quality.
Unreasonable production planning and scheduling:

Solution: Formulate reasonable production plans and scheduling according to market demand and enterprise resources, ensure that processing and manufacturing are carried out in accordance with process flow and operating procedures, and process and assemble raw materials to ensure that product quality meets standards.

What are the cleanliness standards and technical requirements for the production environment of medical devices?

According to the results, the cleanliness standards and technical requirements for the production environment of medical devices are mainly reflected in the following aspects:

Cleanliness level of the production environment: It points out that the setting of the cleanliness level of the production environment of primary packaging materials that are in direct contact with the use surface of implantable sterile medical devices and are used without cleaning should follow the same principle as the cleanliness level of the product production environment. This shows that the cleanliness level of the production environment needs to be set according to the type and requirements of the medical devices produced.

Plant layout and environmental control: It emphasizes the rationality of the overall layout of the plant, and it shall not have adverse effects on the production area of ​​sterile medical devices, especially the clean area. At the same time, it is mentioned that the clean room (area) is an indispensable environment in the production process of sterile and implantable medical devices, and its environmental control level directly affects the product quality.

Sterility and purification requirements of the production process: It is pointed out that GMP has comprehensively improved the cleanliness level of the clean environment of sterile medical device production, and has stricter requirements for sterility and purification of the production process, including the requirement for dynamic monitoring.

Quality management system: It is mentioned that medical device manufacturers should establish and improve a quality management system that is suitable for the medical devices they produce in accordance with the requirements of the medical device production quality management specifications, and ensure its effective operation.

The cleanliness standards and technical requirements for the medical device production environment include but are not limited to: setting a cleanliness level that matches the product type, rationally arranging the plant area to avoid adverse effects on the production area, meeting the sterility and purification requirements in the production process, and establishing and maintaining an effective quality management system.

What are the effects of the medical device production quality control procedure on the internal control standards of the enterprise?

The impact of the medical device production quality control procedure on the internal control standards of the enterprise is mainly reflected in the following aspects:

Clarify responsibilities and personnel qualifications: The quality control procedure requires the enterprise to establish a clear product inspection department and stipulate the qualifications and operating procedures of the personnel. This helps ensure that each link has a dedicated person in charge and has the corresponding professional capabilities, thereby improving overall management efficiency and product quality.

Standardized operating procedures: Quality control procedures include requirements for the use and calibration of inspection instruments and equipment, as well as procedures for product release. These standardized operating procedures can reduce human errors and ensure that every step of production meets the standards, thereby improving product safety and reliability.

Risk management: The ISO 13485 standard requires medical device manufacturers to implement a risk management process to identify, analyze, evaluate and control the risks associated with their products. This systematic approach helps companies to promptly identify potential problems and take measures during the production process to avoid major accidents.

Internal audits and assessments: The quality control procedure also includes internal audits and assessments to ensure the effective operation of the quality management system. Through regular internal audits and assessments, companies can promptly identify and correct existing problems and maintain continuous improvement and optimization of the quality management system.

Set standards based on the actual situation of the company: When formulating quality control procedures, companies need to set them based on their actual situation and national and industry standards. This helps companies better adapt to market changes and regulatory requirements and ensure the scientificity and rationality of their internal control standards.

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Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
Sales: Emma
Tel:+86 571 6991 5082
Mobile: +86 13685785706