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Our Certificates
Quality Managament System Certificates and Made in Mexico Emblema
ISO 13485:2016
We are Certified in the ISO 13485 Quality System for Medical Devices.
1. *Regulatory Compliance: * ISO 13485 certification ensures that we meet regulatory requirements for the manufacturing of medical devices, providing confidence in compliance with safety and quality regulations.
2. *Focus on Risk Management: * The ISO 13485 standard emphasizes risk management in the design and manufacturing of our products and equipment, resulting in making them safer and more reliable.
3. *Process Improvement: * The implementation of a quality management system according to ISO 13485 promotes continuous process improvement, which leads to greater efficiency and quality in production.
4. *Access to International Markets: * The ISO 13485 certification is recognized globally and facilitates our access to international markets, complying with the regulatory requirements of multiple countries.
5. *User Trust: * Our ISO 13485 certification increases user´s trust and demonstrates our commitment to quality and safety in the manufacturing of medical devices.
These advantages may be especially relevant in the context of medical devices, where quality and safety are critical.
ISO 9001:2015
We are certified in the ISO 9001:2015 quality system for the design, manufacture and distribution of equipment for medical gases.
1. *Quality Improvement: * Our certificate ratifies the well-defined processes that guarantee the quality of all our products or services, from design to the manufacturing, also facilitates the product and equipments maintenance, which is an essential requirement in the quality system.
2. *Increased Efficiency: * An ISO quality management system helps improve operational efficiency and reduce waste.
3. *Greater User Satisfaction: * Complying with ISO quality standards, we offer products and services that meet technical and user satisfaction expectations.
4. *Access to New Markets: * ISO certification is an essential requirement to access users in overseas markets.
5. *Continuous Improvement: * One of the fundamental principles of the ISO standard is continuous improvement, which means that we are constantly looking for ways to optimize processes and improve our products and equipment.
“MADE IN MEXICO" Emblema
We are authorized for the “use" of the “MADE IN MEXICO" emblema, which can only be granted by the Ministry of Economy of the Government of Mexico.
1. *Analysis: * Through an assessment and studies carried out by a third party accredited to the SE, and who has the task of exhaustively analyzing the products according to the use of the percentage of raw materials manufactured in the country, in order to be able to grant a designation of origin and the use of the emblem, according to the regulatory guidelines of the Ministry of Economy.
2. *Consumer Trust: * According to the International Monetary Fund (IMF), Mexico is ranked 12th among the best economies in the world, and by being close to the countries of North America (Canada and the USA), we implicitly It requires that the equipment and systems we offer to consumers be at the level of North American countries.
3. *Origin Denomination: * In a globalized economy where the user has several alternatives to using local or international manufacturing equipment brands, it is often unknown and there is no full knowledge of the origin and quality of the components and raw materials that make up the products or equipment offered by those manufacturers.
A product can increase its attractiveness and give certainty to users when the origin of the components and materials with which they were manufactured is known. The authorized use of the “Made in Mexico" stamp provides that certainty and confidence in quality and designation of origin.
4. *Differentiation: * The emblem differentiates the product in the market, as many consumers look for products with the use of the authorized “Made in Mexico" stamp, due to its reputation for quality.
Manufacturing Compliance with the NFPA99 Code
NFPA99
We manufacture and assemble our equipment meeting the recommendations of the NFPA99 code for Medical Gas Systems in Hospitals, Clinics and Laboratories.
1. *Manufacturing: * All our equipment and systems are manufactured based on regulatory compliance under all the recommendations and specifications of the NFPA99 code for Medical Gas Systems and Equipment.
2. *Code Definition: * NFPA99 is a strict code to avoid fire and explosion conditions, as well as the safeguarding of all system users (patients, medical staff and various personnel) in relation to the use of each of the systems , devices, components and equipment that make up a comprehensive medical gas network in a given location (hospitals, clinics and laboratories).
3. *Regulatory Compliance: * The NFPA99 code may become mandatory depending on the country or government agency that has proclaimed it.
Security Product Certificates
UL Certificate
Some of our equipment is certified by Underwriters Laboratories UL, this certification implies that our products were subjected to rigorous laboratory and material resistance tests, to give certainty to the user that they are “safe" and do not involve any type of risk.
1. *Laboratory Tests: * Our products have been subjected to rigorous safety and performance testing in materials analysis laboratories at UL facilities, this means that the product has been test to meet specific stipulated safety and quality standards.
2. *Safety: * UL certification provides peace of mind to the user by ensuring that the product has been evaluated for electrical, fire, chemical and other potential associated hazards.
3. *Acceptance: * Our products have greater acceptance in the market, since many users prefer to purchase products that have been evaluated and certified by a reliable entity such as UL, unlike those products or systems that do not have any type of certification. and have never performed any laboratory analysis.
4. *Regulatory: * UL certification is an important factor in meeting regulatory and policy requirements in different industries and jurisdictions.
The benefits of our UL certified equipment and systems include increased safety in use, verified quality, and regulatory compliance with global market acceptance.
ISO 11197:2019
Some of our products comply with ISO 11197:2019 (Medical Supply Units).
1. *Quality and Safety Guaranteed: * We comply with the ISO 11197:2019 Standard, which means that the product has been designed and manufactured following recognized international standards regarding the quality and safety of medical supply units.
2. *Compatibility and Interoperability: * We comply with technical and regulatory compatibility with other medical equipment, technologies and health systems, which facilitates the integration and adaptation of our products and systems in clinical and hospital environments.
3. *Risk Reduction: * We follow the requirements established in the standard, which reduce the risks associated with the operation of the devices contained in the medical unit, such as errors in the crossing for the administration of medical gases to the patient and the Reduction of risks due to electrical shortcuts and discharges due to the accumulation of static energies.
4. *Regulatory Compliance: * We comply with the ISO 11197:2019 Standard, it helps us visualize the regulatory requirements both, local and overseas in the medical device field.
5. *User Trust: * Our products comply with ISO 11197:2019 to generate trust among users, since they know that they have been manufactured following safety standards established by experts in the field.
The benefits of our products complying with ISO 11197:2019 include guaranteed quality and safety, compatibility, risk reduction, regulatory compliance and user confidence in the product.
ISO 8573-1:2010
Our Medical Air Compressors System are certified with ISO 8573-1:2010 Class 0, for compressed air quality.
1. *Air Purity: * We comply with the ISO 8573-1 Class 0 standard, which guarantees the maximum purity of compressed air, and is crucial in medical applications where the presence of contaminants such as oil, water or particles can be potentially harmful.
2. *Protection of Sensitive Processes: * In addition to the medical environment, the quality and purity of air is guaranteed in processes where high quality air is required to protect sensitive activities and final products, we comply with Class 0 which ensures that the air does not contains contaminants that may affect the quality of the product or process.
3. *Greater Efficiency and Reliability: * By using completely oil-free air compressors pumps, as well devices and components that contribute to compliance with ISO 8573-1 Class 0, we reduce risk of damage to sensitive equipment due to to the presence of contaminants and particles, and results in greater operational efficiency and reliability.
4. *Regulatory Compliance: * In certain industries or applications, compliance with specific compressed air quality standards by ISO 8573-1 Class 0 may be a necessary regulatory requirement to guarantee the safety and quality of the processes.
5. *Less Maintenance: * The need for preventive and corrective maintenance reflected in other components of the integral air network system that could be affected by contaminants will be reduced.
Our equipment certified with ISO 8573-1:2010 Class 0, guarantees the purity of breathing air for human consumption, the protection of sensitive processes, operational efficiency and regulatory compliance with less need for maintenance of components and devices of an compressed air network.
