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Solución de validación del cumplimiento de herramientas/métodos de diagnóstico biológico para los sectores médico y agroalimentario

Resumen

Tipo:
Oferta Tecnológica
Referencia:
TOFR20140506001
Publicado:
01/06/2015
Caducidad:
16/12/2015
Resumen:
Una pyme francesa especializada en evaluación y validación del cumplimiento de métodos y sistemas de diagnóstico in vitro ofrece experiencia ampliamente reconocida en diagnósticos biomédicos para análisis de sistemas/métodos mediante el uso de protocolos para dirigir la evaluación de diagnósticos in vitro CE, cumplir las normas de la FDA y obtener certificados ISO. La empresa también realiza una evaluación clínica y gestiona los aspectos éticos y legales. Se buscan industrias y laboratorios de los sectores médico y agroalimentario con el fin de establecer acuerdos de cooperación o comercialización con asistencia técnica.

Details

Tittle:
Solution for compliance validation of biological diagnostic tools/methods for medical and agrofood sectors
Summary:
A French SME specialized in evaluation and compliance validation of in vitro diagnostic methods and systems, is offering expertise widely recognized in biomedical diagnosis fields for analysis of systems/methods, using protocols or in house protocols to conduct evaluation in respect with CE-In Vitro Diagnostic, FDA compliance, ISO certifications. A Technical cooperation or a Commercial Agreement with Technical assistance is sought with industries / laboratories in Agrofood and Medical sectors.
Description:
The biological analysis processes are now widely automated. As a result, the reagents, devices, and methods have to be evaluated and validated under strict procedures before accessing to market. The device/method updates may also require new evaluation and new certifications.

A French Contract Research Organisation (CRO), specialized in evaluation and compliance validation of in vitro diagnostic methods and systems, has a widely recognized expertise in biomedical diagnosis fields, as well as agrofood and veterinary analytical systems/methods.

The SME has developed a strong know-how and expertise in:
-evaluation of medical diagnostic devices,
-validation of automated processes,
-reagents' evaluation,
-methods' validation,
-comparative studies.

The SME can perform tests:
- within-run precision,
- within laboratories precision,
- detection range,
- interferences,
- cross contaminations

Using protocols or in-house protocols to conduct each evaluation in respect with specific needs (CE-IVD, FDA compliance, ISO certifications...), the SME offers dedicated solutions and tailor made services and can help in generating data in labs as outsourced expert (dedicated technicians and biologists) insuring strict confidentiality.

In addition to biological aspects, the SME is also able to set a clinical evaluation and manage all ethic and legal aspects.

Technical cooperation or Commercial agreement with Technical assistance are sought with industries / laboratories in Medical and Agrofood sectors.
Advantages and Innovations:
Confidentiality (Non-disclosure Agreement)
Tailored-made tests and validation
Quality certified (ISO9001)

Tests performed:
- within-run precision,
- within laboratories precision,
- detection range,
- interferences,
- cross contaminations
Stage of Development:
Already on the market
IPs:
Secret know-how

Partner sought

Type and Role of Partner Sought:
Manufacturers of reagents and devices for in vitro diagnostic and analysis (blood, urine, biological fluids...) who are seeking experts for evaluation of their systems in alpha and beta sites and to manage clinical studies.

Laboratories (medical, agrofood, veterinary...) with methods to be evaluated and validated by alpha and beta sites.

Industrials or university that need to test their products and innovations in real but protected situations.

The partner will bring the systems to be tested and the French company will run the evaluations under current protocols in ISO 9001 and ISO 17025 processes.

Client

Type and Size of Client:
Industry SME <= 10
Already Engaged in Trans-National Cooperation:
Si
Languages Spoken:
English
French

Keywords

Technology Keywords:
06002001 Bioquímica / biofísica
06001005 Diagnósticos, diagnosis
09001003 Ensayos de material químico
06002007 Ensayos in vitro, experimentos
09006001 Normas de calidad