Tonglu Wanhe Medical Instrument Co., Ltd.
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FAQ
The international quality standards for minimally invasive surgical instruments mainly include the following aspects:
Quality management system certification: For example, the German SPINENDOS full spinal endoscope system complies with the international standards DIN EN ISO9001 and DIN EN ISO 13485 quality management system certification. These certifications ensure that companies follow internationally recognized standards in production and management.
EU CE certification: Many minimally invasive surgical instruments need to pass the EU CE certification to prove that they comply with the EU Medical Device Regulation (MDR). For example, Lanfan Surgical Electric Laparoscopic Stapler has successfully obtained EU CE MDR certification.
US FDA certification: Some companies will also apply for certification from the US Food and Drug Administration (FDA) to ensure the legality and safety of their products in the US market.
International Organization for Standardization (ISO) standards: For example, the ISO 13485 standard is a requirement for the quality management system of medical devices for regulations and is widely used in the quality management of minimally invasive surgical instruments.
Accredited laboratory qualifications: The accredited laboratory (QTL) qualifications issued by international organizations such as SGS are also one of the important standards for measuring the quality of minimally invasive surgical instruments.
National Endoscopic Minimally Invasive Technology and Standards International Center: The center is committed to jointly researching and formulating internationally unified quality standards with countries around the world to ensure medical safety and improve medical quality.
Industry standards and testing capabilities: Some companies have strong testing capabilities and rich testing items, and use international, domestic and industry standards for product quality control.
International quality standards for minimally invasive surgical instruments cover many aspects, including quality management system certification, EU CE certification, US FDA certification, ISO standards, accredited laboratory qualifications, and research results of the National Endoscopic Minimally Invasive Technology and Standards International Center. These standards and certifications jointly ensure the safety, reliability and high quality of minimally invasive surgical instruments.
In the German SPINENDOS full spinal endoscope system, minimally invasive surgical instruments comply with the DIN EN ISO 9001 and DIN EN ISO 13485 quality management system certifications in the following ways:
DIN EN ISO 9001 certification: This standard focuses on the quality management system of an organization to ensure that it can continuously provide products and services that meet customer and legal and regulatory requirements. Passing the DIN EN ISO 9001 certification means that the production process and quality management system of minimally invasive surgical instruments have reached internationally recognized standards and can ensure product quality and consistency.
DIN EN ISO 13485 certification: This standard is specifically for the quality management system of medical devices, ensuring that every link from design, manufacturing to delivery and use of medical devices meets strict quality control requirements. Passing the DIN EN ISO 13485 certification indicates that the production and management process of minimally invasive surgical instruments meets the specific requirements of the medical device industry and ensures their safety and effectiveness.
In addition, DIN EN ISO 13485 also corresponds to the EU Medical Device Regulation (EU MDR), which means that minimally invasive surgical instruments that pass this certification can more easily enter the EU market and meet relevant regulatory requirements.
The safety assessment standards of minimally invasive surgical devices by the U.S. Food and Drug Administration (FDA) include the following aspects:
Material safety: The FDA will focus on whether the materials in the device will cause harm to patients, especially metal-on-metal total hip replacement medical devices and breast implants.
Technical document review: During the preliminary review stage, FDA auditors will check the submitted documents to ensure their completeness and accuracy. If deficiencies or problems are found, the FDA may ask questions or request additional information from the manufacturer.
Design, specifications and manufacturing: The FDA will review the product's technical documents, including design, specifications and manufacturing processes, to ensure that the device meets relevant standards.
Risk management: The FDA emphasizes risk management activities and risk-based decision-making, aiming to reduce the regulatory burden on device manufacturers and importers by coordinating domestic and international requirements.
Clinical trials: For certain high-risk devices, the FDA requires clinical trials to prove their safety and effectiveness. For example, the hip product of MicroPort® Orthopedics has obtained FDA 510(k) registration approval, which means that its safety and effectiveness have been recognized.
Quality Management System: FDA requires medical device companies to comply with the Quality Management System Regulation (QMSR) to ensure that medical devices on the market are safe, effective, and high-quality.
Cybersecurity and Use of Radiation: FDA also focuses on important topics such as cybersecurity and use of radiation for medical devices and covers these aspects when updating its list of pre-market medical device consensus standards.
What is the importance of accredited laboratory (QTL) qualifications such as SGS for quality control of minimally invasive surgical devices?
The importance of accredited laboratory (QTL) qualifications such as SGS for quality control of minimally invasive surgical devices is mainly reflected in the following aspects:
Strengthen product compliance: QTL accredited laboratory qualification is issued by SGS and is only awarded to corporate laboratories with ISO 17025 laboratory management system capabilities. This means that laboratories that obtain this qualification can ensure that their testing and certification processes meet international standards, thereby improving product compliance.
Improve test fairness: QTL accredited laboratory qualification is designed to accelerate product launch while maintaining the fairness and accuracy of testing. This is especially important for products such as minimally invasive surgical devices that require rigorous testing to ensure safety and effectiveness.
Improve certification efficiency: By obtaining QTL accredited laboratory qualifications, companies can conduct product certification and testing more efficiently. For example, after obtaining the qualification, the level of its certification testing personnel and testing equipment capabilities of Elis have been fully recognized, which effectively improved the efficiency of certification.
Promote technological innovation and market entry: QTL accredited laboratory qualifications help companies gain more shares in the international market and quickly enter the target market. This can significantly enhance the competitiveness of companies for high-tech products such as minimally invasive surgical instruments.
Ensure product quality and safety: QTL accredited laboratory qualifications require companies to operate in accordance with international quality standards, thereby continuously improving the reliability and safety of products. This is crucial for products such as minimally invasive surgical instruments that have extremely high requirements for quality and safety.
The National Endoscopic Minimally Invasive Technology and Standards International Center plays an important role in formulating internationally unified medical device quality standards. The center was approved by the Ministry of Science and Technology to promote the development of endoscopic minimally invasive medicine and to collaborate and innovate to establish an international alliance of industry, academia and research. The center's main tasks include equipment development and standard formulation, actively contacting relevant institutions and industry experts from countries and regions around the world, and gradually forming an integrated cooperation system of government, industry, academia and research. In addition, the center is also committed to expanding the scope and channels of international scientific and technological cooperation, strengthening talent training and innovation team building, and realizing the effective integration of projects, bases, and talents.
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Company Name: Tonglu Wanhe Medical Instruments Co., Ltd.
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