News and updates of plastic containers
Conformity labeling and the new European directives for medical devices (MDR)
In the plastic manufacturing industry, we must be aware that health products and plastic packaging for the pharmaceutical sector are of special care, since it is in a continuous state of progress and change in processes. That is why Triana, a pioneer in this...
8 Characteristics of the health products offered by Triana
In short, all those materials that are used in human beings for the purposes of diagnosis, treatment, control or prevention of a disease, injury or deficiency are known as Medical Devices. The material concept encompasses everything from computer programs to equipment, medical instruments or devices designed for the purposes. In this sense, Triana’s sanitary products comply with the definition and the following characteristics concur in all of them.
Application of risk management in the manufacture of medical devices
It is ISO-14971 that determines how to carry out risk management in the manufacture of medical devices. This norm establishes the standards and specifications with which the manufacturing process must comply. The problem, however, is that these standards and...
Clean room for the manufacture of sanitary products
Any company dedicated to production, regardless of the sector and the products that make up its catalog, must ensure that its processes are carried out in a controlled environment free of any contaminating element. In this way the maximum integrity of the product is...
EU MDR: 5 regulatory requirements to market a medical device
The EU MDR standard is basic for the professional group involved in the marketing of medical devices. From manufacturers, authorized representatives, importers, or distributors of medical devices in the European Union (EU). These professionals must be up to date with...
EUDAMED database: Traceability and transparency of the CE marking
The EUDAMED database contains many routine and in vitro diagnostic medical devices from the single market. It also has another role that makes it indispensable. It is a platform that allows interaction between manufacturers and authorities, among other agents...
The most popular pharmaceutical packaging
Getting to know about the types of pharmaceutical packaging on the market is an essential first point. And it is necessary to find the one that best suits the particular characteristics of the substances they are going to contain. For this reason, it is essential to...
What is the regulatory framework for medical devices?
The regulatory framework for medical devices is a primary issue since it establishes the guidelines to be met by these types of products in relation to the different areas. Thus, both manufacturers and distributors or authorized representatives must be fully informed...
What is the ISO 13485 standard? | Quality management systems
The ISO 13485 standard is a fundamental certification for manufacturers of medical devices. Therefore, knowing closely what it consists of and what its effects are is information to keep in mind in the course of this activity. At IP Triana, we take our work very...
ISO 9001 Certification: What is the ISO 9001 standard?
The ISO 9001 standard is a well-known normative compendium especially for those, people or companies, who implement a quality management system in their businesses. Well, this is precisely what this regulation is about: quality. And specifically, it is about...
Aspects that are considered to manufacture a medical device
Manufacturing a medical device, whatever it may be, is an action for which a company needs to be specially prepared since its production requires the fulfilment of very demanding requirements. This is really very easy to understand, since we are talking about products...
What is considered a medical device? | Classification
The concept of a medical device is something whose limits are important to define, especially as they affect the technical and legal field of especially sensitive articles. It is also important, on the one hand, because of their close relationship with medicine and on...