B.Well obtains a Quality Management System according to ISO 13485:2016. ISO - the International Organization for Standardization - is an international non-governmental organization with a membership of 165 national standard bodies. It develops and publishes a wide range of proprietary, industrial, and commercial standards and is composed of representatives from various national standards organizations. Health care devices also fall under the expert scope. The quality management system for medical devices falls under 13485. The number “2016” shows the version of the standard.
Having a quality management system ISO 13485 allows a producer, such as B.Well, to apply for CE Certification for each product.
Medical Device Directive 93/42/EEC (MDD) or Medical Device Regulation (EU) 2017/745 (MDR)
Medical Device Directive (MDD) 93/42/EEC is one of the European Union (EU) Directives. It is intended to define safety and performance requirements that a medical device needs to fulfil within the EU to legally place a medical device on the European Market. This is only possible if the product meets all quality requirements like efficiency, safety, easy to use (a person should understand how the product works), no biological hazard, etc. Products must carry a CE mark in compliance with the MDD.
The CE marking is a manufacturer's declaration that the product meets EU requirements for health, safety, and environmental protection. It is internationally recognized as a quality sign. All B.Well products have CE. The control organ, so-called Notified Body, checks everything in detail and verifies that the devices meet all applicable standards. CE0044 on all medical devices of B.Well states that the German Notified Body “TUEV NORD Cert. GmbH” is acting on our side.
With these certificates B.Well is free to trade goods legally in 25 countries within the European Common Economic Area (EEA). Due to a very high level of quality assurance, many countries outside Europe also accept CE certified products as a reliable base for local registrations. The Medical Devices Directive (MDD) is being repealed and replaced by the 2017 EU Medical Device Regulation (EU 2017/745) (MDR). Our team is prepared to fulfil the new requirements. They are to come into effect on 26 May 2021. We spare no effort in offering the best quality products to our valued customers.
A big group of internal and external professionals developed and tested the products. Only after a successful approval from all sides, they have been sent through the International Certification Process. As a result, B.Well Swiss’s CE Mark ensures reliability, safety and an easy way to use, and makes millions of families happier.