Biochem aims to meet the growing and increasingly complex needs of customers by offering a professional service and individual care, tailored to the needs of the customer. Biochem has developed over the years a range of services, ranging from assist the customer in the choice of analysis to be performed, to deepen technical and scientific results obtained.

Assistance in the choice of tests

Our highly qualified and multidisciplinary staff offers on contract Scientific-Technical Support.

The staff supports you in choosing the most appropriate analytical tests to be carried out in relation to the type of product or process and according to your goals.
The staff helps you choose the tests taking account of other information already available and other useful criteria, for example, the drafting of the Technical File or Risk Analysis.
This range also covers the food and catering industry for the application of the HACCP system,
The staff works closely with the commercial Department to better and promptly respond to your requests.


 If you have not found the test or service of your interest please contact our Sales Department.

Evaluation of the results

The service of evaluation and interpretation is an essential part of the technical files.

Usefully to guide business and productive decisions after testing a product to enter the market, our Staff of Scientific-Technical Support provides, on contract, the services of evaluation and interpretation of results in relation to current legislation, to the existing literature, the analysis of risk, protocols or other requirements applied and considering also the predicted use of product or process or material.
Along with the evaluation of the performance of service we provide scientific and technical support, with a multidisciplinary approach to the resolution of problems emerged and the design of new or alternative solutions. The staff works closely with the commercial Department to better and promptly respond to your requests.


If you have not found the test or service of your interest please contact our Sales Department.

Toxicological Evaluations

The toxicological profile is a key factor in the development and production of new medical devices and is a essential part of the technical files.

Our Staff of Scientific-Technical Support provides, on contract, the service evaluation of the products and results of toxicological. The studies of toxicological evaluation allow to evaluate the interactions between chemical compounds and biological systems, in order to determine possible adverse effects. The toxicology aims to understand the nature and impact of these effects on living organisms, evaluating the biological alterations induced.

The staff, characterized by specific knowledge and high competence, leads with a multidisciplinary approach to toxicological evaluations comparing chemical data and biological effects. We carry out the evaluation of leachables (ISO 10993-17 "Establishment of allowable limits for leachable substances") and the interpretation of biocompatibility tests considering the existing scientific literature, to support you in the objective of ensuring the safety of your products, and in particular to support you in compiling the Technical files and Risk Analysis.


 If you have not found the test or service of your interest please contact our Sales Department.

Clinical Eavluation, Technical dossiers, PIF, Preclinical Trials

Our staff provides answers customized to your needs competent and competence.
We can provide:

Clinical Evaluation according to the last revision MEDDEV 2.7/1 revision 4

preparation of technical dossiers to identify any contraindications and to demonstrate compliance with the provisions of law, for example, to obtain the CE mark Directive (Directive 2007/47 EC); preparation of P.I.F. (Product Information File) in accordance with the requirements of Regulation (EC) n.1223/2009; drafting of the dossier on cosmetics and safety assessments of the same; design and drafting of Operational Management Procedures; assistance in preparing for the audit and for the qualification of suppliers; planning services and cooperation.

Clinical preclinical Trials

Biochem may supply you with consultancy and/or tests in order to demonstrate the absence of pharmacological activity of your medical devices


 If you have not found the test or service of your interest please contact our Sales Department.

Risk Analysis

In the Medical Devices field the Risk Analysis is conducted in accordance with the requirements of ISO 14971 “Medical devices - Application of risk management to medical devices”.

This standard is the basis for dealing with the assessment of compliance with the mandatory requirements set by the European and national legislation in the field of medical devices, of In vitro diagnostic medical devices (IVD), and of active implantable devices (Directives 93/42/EEC, 90/385/EEC and 98/79/EC and subsequent amendments and supplements). The Risk Analysis should cover all stages of the life cycle of a device, from design to information of production and post-production.

See http://www.salute.gov.it/portale/temi/p2_4.jsp?lingua=italiano&area=dispositivi-medici you can see the portal of the Italian Ministry of Health, where you can find information, updates, regulatory references and utility tools.


 If you have not found the test or service of your interest please contact our Sales Department.

Manuale d'uso e Manutenzione

Verifica della redazione del manuale d’uso e manutenzione.

Questo documento è fondamentale per la prevenzione e la sicurezza del prodotto, riduce le richieste di assistenza e chiarimenti sull’utilizzo del dispositivo e permette di definire i limiti di responsabilità legale del fabbricante.

I nostri tecnici sono in grado di redigere tutte le informazioni necessarie per la stesura del manuale in linea con tutti gli standard normativi di riferimento.

Audit

Audit e supporto durante audit per verificare la conformità del sistema e dei processi produttivi.

Biochem, parte del Gruppo White Lab, offre un servizio di audit in situ per controllare la corretta applicazione di standard internazionali e assegnare l’adeguata copertura alle attività aziendali che presentano maggiore grado di rischio.

Gli audit sono condotti in accordo alla norma ISO 19011 da tecnici esperti nel settore.

Inoltre, grazie alla collaborazione con gli Organismi Notificati, offriamo supporto in qualità di auditor esterni per la verifica di mantenimento o di certificazione iniziale del prodotto.

Training

Biochem offers customized training plans and courses. Biochem provides you with the best multidisciplinary and skills acquired through continuous training and direct experience.

Some areas of training:
▫ Validation of sterilization processes
▫ Validation of packaging
▫ How to work in aseptic
▫ Hygiene of the staff and working
▫ Check the calibration

Biochem also offers a service of Informative Update on Laws, Rules, Pharmacopeia of areas concerning medical devices, packaging materials and food contact, SDS.


 If you have not found the test or service of your interest please contact our Sales Department.

CONTACTS

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