Quality, safety and continuous improvement in the development and manufacture of your medical devices
Neftis Laboratorios is a contract manufacturer that was set up in 2005. All these years of experience have allowed us to develop, formulate and manufacture professional cosmetics and medical devices, in addition to offering the corresponding technical and documentary support pursuant to the legislation of each country.
Neftis Laboratorios is certified to manufacture medical devices
At Neftis Laboratorios, we develop medical devices in accordance with the UNE-EN ISO 13485 standard (quality management systems for medical devices).
This international standard is an extension of Annex IX of the UE Regulation on medical devices 2017/745 which proposes a conformity evaluation system based on a quality management system and the evaluation of the technical documentation.
The ISO 13485 standard is focused on the management of processes and their risks, continuous improvement and satisfying the needs and expectations of the client. By complying with this standard, Neftis Laboratorios proves its ability to provide medical devices that consistently meet the requirements of clients and the applicable regulatory requirements.
Neftis Laboratorios obtained this certification in 2016 within the scope of subcutaneous sterile products for injection and sterile and non-sterile products for topical use. Compliance with this standard guarantees the efficacy and safety of the medical devices during each product life cycle phase, guaranteeing that the product has been developed using a high quality process that is free of risks for the end user, as every step in the chain is thoroughly evaluated, controlled and submitted to the strictest checking processes.
We develop much more than formulas
The main function we carry out for our clients is to materialise the entire process of manufacturing a cosmetic or a medical device, from the development of the initial idea to obtaining the finished product. The Neftis team participates in each one of the required phases: design, development, manufacture, filling and final packaging. And we do all this in addition to an advisory service on regulatory affairs that provides support to clients in registering the product and completing the product information file (PIF) pursuant to the EU legislation.
Neftis Laboratorios is also certified to the ISO standard UNE-EN ISO 22716 (Good Manufacturing Practices for Cosmetics) to accredit that the cosmetics we manufacture comply with an internationality standard of quality, safety and efficiency