Specialists in assisting and supporting the research, development, and regulation of ophthalmic products
In accordance with Standard EN ISO 10993-5:2009, quantification of cell viability using the MTT assay on different cell lines after the administration of compounds or extracts.
In accordance with Standard EN ISO 11979-5:2020, verification of the potential compatibility or irritation capacity in ocular tissues of products or materials used in pharmacology or medical devices.
In accordance with EN ISO 11981:2018, determination of the physical compatibility (variations in base curve, power, diameter, spectral transmittance, and physical appearance) of contact lens care products with the lenses.
Determination of a product's ability to remove compounds from the surface of contact lenses, or a product's capacity to be removed from the surface of contact lenses during care.
Determination of the capacity of contact lens cleaners to remove proteins (present in tears) from the lens surface.
Determination of the capacity of contact lens cleaners to remove lipids (present in tears) from the surface of the lenses.
Determination of TFSQ parameters based on the dehumidification ratio of contact lenses in maintenance solutions and artificial tears to improve their wearability and lubrication.
Assessment of the alteration of physicochemical properties (Standard EN ISO 11981:2018) of contact lenses and the growth of microorganisms (UNE-EN ISO 11978:2018/A1:2021) after long periods of preservation in maintenance solutions.
In accordance with EN ISO 10993-5:2009. Quantification of cell viability using the MTT technique in different cell lines, before the administration of compounds or extracts.
Product pre-market trials, safety, effectiveness, risk analysis, usability.
Diseño según situación y realización de estudios post-comercialización, recopilación de datos clínicos del uso en humanos de dispositivos médicos.
Generación, diseño, coordinación y realización de ensayos clínicos de productos oftalmológicos.
Asesoramiento, diseño, formulación y fabricación (escala prueba) de nuevos productos según requerimientos del cliente.
Realización de estudios regulatorios de productos sanitarios oftálmicos bajo los reglamentos (UE) 2017/745 y (UE) 2017/746.
Ocupharm diagnostic S.L. es una empresa especializada en la asistencia y ayuda a la investigación, desarrollo y regulación de productos oftalmológicos.
C/Arcos de Jalón 118, Madrid 28037
+(34)645 773 081
info@ocupharm.com
L a V: 8:00 a 15:00
