Dear clients and biofeedback therapists, we know that quality and reliability are of utmost importance to you when working with biofeedback devices and conducting training sessions. Certificates are official documents that prove our products and services comply with international standards and regulations.
Unfortunately, some companies sell devices without the proper certifications, which can pose significant risks. Uncertified devices can lead to:
Without certification, devices may not meet the necessary calibration and quality control standards, resulting in unreliable data. This can lead to incorrect diagnoses and treatments, endangering patients’ health.
Such devices may not be manufactured with materials and processes that meet strict quality requirements, increasing the risk of failure. A malfunctioning device can fail during a training session, compromising the safety of both patients and therapists.
Uncertified devices may not meet basic safety standards, leading to electrical issues, overheating, or other dangerous situations.
Certificates ensure that devices meet local and international laws and standards. Using uncertified devices can lead to legal issues and put your business at risk..
These certificates are particularly important in the global market as they enhance our company’s credibility and competitiveness. Therefore, always be cautious and use only certified devices to ensure safety and reliability in your work.
Obtaining and maintaining certificates is crucial for our company’s credibility. These certificates demonstrate that we adhere to the highest quality and safety standards, increasing your trust in us. Possessing certificates shows our commitment to quality and continuous improvement, ensuring you always work with the best tools and services.
Your trust is of paramount importance to us. Certificates have a significant impact on customer trust. You often prefer products and services that come with certifications, as these guarantee quality and reliability. With certificates, we can more easily gain the trust of new customers and retain our existing ones.
Our company has obtained various certificates to ensure we provide you with the highest level of quality and safety. Below, we will provide a detailed description of the most important certificates we hold.
ISO 9001 is one of the most widely recognized and well-known quality management system standards. This certificate proves that we operate an effective quality management system that meets international standards, ensuring your satisfaction and continuous improvement.
The ISO 13485 standard specifically prescribes the quality management system for medical devices. This certificate shows that our products comply with the strictest regulations for manufacturing medical devices, ensuring patient safety and your peace of mind during training sessions.
The GMP (Good Manufacturing Practices) certificate demonstrates that we follow the highest manufacturing practices that guarantee the quality and safety of our products. This is particularly important for you, as it ensures our biofeedback devices are reliable and of high quality.
The CE marking indicates that our products comply with the safety, health, and environmental regulations of the European Union. This certificate is essential for our products to be marketed in the European market, ensuring the reliability and safety of the products you use
The ISO 9001 standard defines the requirements for quality management systems that help ensure consistent quality of products and services. Obtaining and maintaining ISO 9001 certification offers numerous benefits, including improved customer satisfaction, increased process efficiency, and enhanced market competitiveness. For you, this means always working with the best tools
The ISO 13485 standard specifically applies to the manufacturing of medical devices, prescribing the highest levels of quality assurance and regulation. This certificate ensures that our products meet strict medical device regulations, essential for ensuring patient safety and giving you peace of mind during training sessions.
The GMP (Good Manufacturing Practices) certificate ensures that we follow the best manufacturing practices that guarantee the quality and safety of our products. Adhering to GMP standards is particularly crucial in the food and pharmaceutical industries, but it is also significant for you, as our biofeedback devices are always reliable and of high quality.
The CE marking certifies that our products comply with the legislative requirements of the European Union, including safety, health, and environmental protection standards. This certificate is essential for marketing our products in the European market, ensuring that our products are reliable and safe, just as you expect.
To obtain ISO 9001 certification, we first need to assess our current quality management systems and align them with the standard’s requirements. This is followed by an external audit, and if we meet all the requirements, the certificate is issued. For you, this means we always ensure the highest quality.
To obtain ISO 13485 certification, we also need to assess and establish a quality management system that meets the standard’s requirements. The auditing and certification process is similar to that of ISO 9001. This ensures that Å‘rű medical devices always represent the highest quality.
The GMP (Good Manufacturing Practices) certificate ensures that we follow the best manufacturing practices that guarantee the quality and safety of our products. Adhering to GMP standards is particularly crucial in the food and pharmaceutical industries, but it is also significant for you, as our biofeedback devices are always reliable and of high quality.
To obtain CE marking, we must ensure that our products comply with the relevant EU legislation and standards. This may include product testing, preparing documentation, and issuing a declaration of conformity. This guarantees that our products are safe and reliable, just as you expect.
Certificates offer numerous benefits for our company and for you. These include improved market position, increased customer trust, compliance with regulatory requirements, and enhanced efficiency of internal processes. Additionally, certificates contribute to enhancing our company’s reputation and credibility, ensuring you always work with the best tools.
Obtaining and maintaining certificates can be challenging, as it can be a time-consuming and costly process. We need to continually ensure compliance with standards, which may require regular internal and external audits. Additionally, standards are frequently updated, so we need to keep our systems and processes up to date. For you, this means we always provide the best and safest tools.
To manage the challenges of certificates, it is important to be well-prepared and allocate the necessary resources and expertise for the certification processes. Additionally, it is beneficial to work with experienced consultants and auditors who can help effectively manage the processes and meet the requirements. This ensures that you can always be confident that we represent the highest level of quality.
ISO 9001 certification is an international standard that defines the requirements for quality management systems. It is important because it helps companies ensure consistent quality of products and services, increasing customer satisfaction and market competitiveness.
ISO 13485 certification applies to the quality management system for medical devices. It is important because it ensures that a company's products meet the highest levels of medical device regulations, which is essential for ensuring patient safety.
The GMP (Good Manufacturing Practices) certification ensures that a company follows the best manufacturing practices that guarantee the quality and safety of products. It is particularly important in the food and pharmaceutical industries.
The Medical CE marking indicates that a product complies with the legislative requirements of the European Union, including safety, health, and environmental protection standards. This certificate is essential for marketing products in the European market.
Certificates offer numerous advantages, including improved market position, increased customer trust, compliance with regulatory requirements, and enhanced efficiency of internal processes.
Obtaining certificates can be time-consuming and costly. Companies need to continually ensure compliance with standards, which may require regular audits.
Dear clients and biofeedback therapists, obtaining and maintaining certificates is essential to ensure the quality, reliability, and safety of our products and services. These certificates enhance our company’s credibility, improve our market position, and increase your trust in us. We know that quality and reliability are of utmost importance to you, and we are committed to always providing you with the best tools and services.
Impressum
This website is operated by Mandelay Kft.
Budapest, Hungary
Address: 2310 Szigetszentmiklos, Gyartelep 120001/33 Hrsz.
Tel: +36 (20) 250-7190 (HU)
EU TAX nr: 23586310-2-13
E-mail: info@vibeyoup.com
Please note that our office is open from Monday to Friday from 10 until 17 CET.
Current time in Hungary