Quality and safety
Quality and certification
Customers worldwide rely on us to provide high-quality products for their medical device manufacturing and assembly processes. Some of the most well-known and influential medical device manufacturers in the world trust our solutions.
Our parent company Tecnoideal follows the fundamental concepts and principles of quality management when manufacturing our products and services. Thus, we adhere to ISO 9000:2015 guidelines.
Certification
Tecnoideal has developed a certified quality management system to ensure the effectiveness of our processes.
Full compliance with certifications assures that all regulatory and product performance requirements are met, assuring the respect of the highest quality standards.
The ongoing dialog with customers and our natural tendency to pay attention to market needs and trends strengthen our steady commitment to continuously improve our products.
Tecnoideal designs, assembles and tests active medical devices on behalf of the MEDICA Group to which it belongs.
- In its role as a critical supplier of Medica, Tecnoideal has developed a quality management system that assures the reliability and very high performance required by the production of medical devices.
- The same system, also applied to semi-automatic machines, ensures that the quality of products for which Tecnoideal is Legal Manufacturer largely exceeds the competitors', enhancing our image and brand.
Safety and environment
All Tecnoideal products are made with materials conforming to European directive 2011/65/EU (also known as RoHS or Restriction of Hazardous Substances), limiting the use and environmental dispersion of specific hazardous materials found in electrical and electronic products, such as cadmium, lead, mercury, hexavalent chromium, polybrominated biphenyls (PBBs) and polybrominated diphenyl ethers (PBDEs).
Furthermore, Tecnoideal products conform to Regulation (EC) no 1907/2006 of the European Parliament and of the Council of December 18, 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH).
Tecnoideal's primary goal is to make sustainable products, respecting the environment and fostering a truly sustainable development.
The safety of Tecnoideal employees is paramount. The entire production takes place using safe stations and equipment safeguarded by the most advanced safety systems, fully conforming to Legislative decree 81/08 (Consolidated law on health and safety on the workplace).