ISO 13485, a medical electrotechnical quality certificate

In the world of medical devices, quality and safety are essential. To ensure compliance with the highest standards, there is ISO 13485, an international certification specific to companies that manufacture these devices. This recognition demonstrates that a company not only complies with regulatory requirements, but also follows strict quality management protocols. In this context, Electrolomas positions itself as a benchmark, marketing trustworthy products for its customers in critical sectors.

ISO 13485, nature and characteristics

ISO 13485 is an international standard that establishes the requirements for quality management (QMS) in the design and manufacture of medical devices. Based on ISO 9001, but with a specific focus on medical devices, it seeks to ensure that medical devices and their components are safe and effective.

It also concerns the final devices and the electronic components and circuits that integrate them. This is decisive in activities such as electromedical and laboratories.

For Electrolomas, this standard is crucial, since its line of electronic circuit manufacturing, both rigid and flexible, meets the rigorous criteria of certification. Only in this way can it guarantee the reliability and safety of its products. This certification is crucial to comply with regulatory requirements in international markets.

Advantages of having suppliers with this UNE standard in ISO

Having a supplier that holds the ISO 13485 certification, such as Electrolomas, brings several tangible benefits for any client who needs high-quality components. Among the most notable are:

• Quality and safety guarantee. Its support ensures that products and services meet the highest international standards. This translates into safe and reliable products.
• Regulatory compliance. Having certified suppliers favors compliance with the regulatory standards required to market medical products in different markets, such as the European Union or the United States.
• Improved operational efficiency. The implementation of this standard optimizes production processes, which results in shorter delivery times.
• Trust in the supplier. Knowing that a supplier, such as Electrolomas, has been subjected to strict audits and quality controls generates a higher level of trust, something imperative in sectors as sensitive as health.
• Innovation and continuous development. Organizations that comply with this standard demonstrate their ability to adapt and continually improve their products.

Electrolomas provides products that comply with the regulations, while providing a personalized service. Its objective is to respond to the specific requirements of each client, with the certainty that its products comply with the UNE regulation in ISO 13485.

In short, the ISO 13485 certification represents a quality standard and a commitment to safety in the medical sector. Electrolomas, with its extensive experience and certification in medical devices, is a reliable ally for any company that requires products and components for medical devices. Those interested in further information or in receiving personalized advice should contact them directly or follow them on social networks to stay up to date.