{"id":78,"date":"2022-01-12T10:32:21","date_gmt":"2022-01-12T10:32:21","guid":{"rendered":"http:\/\/www.biochem-bcm.com\/?page_id=78"},"modified":"2025-10-22T14:41:16","modified_gmt":"2025-10-22T14:41:16","slug":"servizi","status":"publish","type":"page","link":"https:\/\/www.biochem-bcm.com\/en\/servizi\/","title":{"rendered":"SERVICES"},"content":{"rendered":"
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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.<\/p>\n\n\t

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\n\t\t\t\tAssistance in the choice of tests<\/span>\n\t\t<\/svg>\t<\/div>\n\n\t
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Our highly qualified and multidisciplinary staff offers on contract Scientific-Technical Support.<\/p>\n<\/div>\n

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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.
\nThe 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.
\nThis range also covers the food and catering industry for the application of the HACCP system,
\nThe staff works closely with the commercial Department to better and promptly respond to your requests.<\/p>\n


\u00a0If you have not found the test or service of your interest please contact our Sales Department.<\/a><\/span><\/p>\n<\/div>\n\n\t

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\n\t\t\t\tEvaluation of the results<\/span>\n\t\t<\/svg>\t<\/div>\n\n\t
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The service of evaluation and interpretation is an essential part of the technical files.<\/p>\n

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.
\nAlong 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.<\/p>\n


If you have not found the test or service of your interest please contact our Sales Department.<\/a><\/span><\/p>\n<\/div>\n

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\n\t\t\t\tToxicological Evaluations<\/span>\n\t\t<\/svg>\t<\/div>\n\n\t
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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.<\/p>\n<\/div>\n

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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.\nThe toxicology aims to understand the nature and impact of these effects on living organisms, evaluating the biological alterations induced.<\/p>\n

The staff, characterized by specific knowledge and high competence, leads with a multidisciplinary approach to toxicological evaluations comparing chemical data and biological effects.\nWe 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.<\/p>\n<\/div>\n<\/div>\n


\u00a0If you have not found the test or service of your interest please contact our Sales Department.<\/a><\/span><\/p>\n\n\t

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\n\t\t\t\tClinical Eavluation, Technical dossiers, PIF, Preclinical Trials<\/span>\n\t\t<\/svg>\t<\/div>\n\n\t
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Our staff provides answers customized to your needs competent and competence.
\nWe can provide:<\/p>\n

Clinical Evaluation according to the last revision MEDDEV 2.7\/1 revision 4<\/p>\n

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.<\/p>\n

Clinical preclinical Trials<\/strong><\/p>\n

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


\u00a0If you have not found the test or service of your interest please contact our Sales Department.<\/a><\/span><\/p>\n<\/div>\n

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\n\t\t\t\tRisk Analysis<\/span>\n\t\t<\/svg>\t<\/div>\n\n\t
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In the Medical Devices field the Risk Analysis is conducted in accordance with the requirements of ISO 14971 \u201cMedical devices - Application of risk management to medical devices\u201d.<\/p>\n<\/div>\n

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The Risk Analysis must cover all phases of the medical device life cycle, from design to production and post-production information.<\/p>\n

See\u00a0http:\/\/www.salute.gov.it\/portale\/temi\/p2_4.jsp?lingua=italiano&area=dispositivi-medici<\/a>\u00a0you can see the portal of the Italian Ministry of Health, where you can find information, updates, regulatory references and utility tools.<\/p>\n


\u00a0If you have not found the test or service of your interest please contact our Sales Department.<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\t

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\n\t\t\t\tManuale d'uso e Manutenzione<\/span>\n\t\t<\/svg>\t<\/div>\n\n\t
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Verifica della redazione del manuale d’uso e manutenzione.<\/p>\n

Questo documento \u00e8 fondamentale per la prevenzione e la sicurezza del prodotto, riduce le richieste di assistenza e chiarimenti sull\u2019utilizzo del dispositivo e permette di definire i limiti di responsabilit\u00e0 legale del fabbricante.<\/p>\n

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.<\/p>\n<\/div>\n

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\u00a0If you have not found the test or service of your interest please contact our Sales Department.<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\t

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\n\t\t\t\tAudit<\/span>\n\t\t<\/svg>\t<\/div>\n\n\t
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Audit e supporto durante audit per verificare la conformit\u00e0 del sistema e dei processi produttivi.<\/p>\n

Biochem, parte del Gruppo White Lab, offre un servizio di audit in situ<\/em> per controllare la corretta applicazione di standard internazionali e assegnare l\u2019adeguata copertura alle attivit\u00e0 aziendali che presentano maggiore grado di rischio.<\/p>\n

Gli audit sono condotti in accordo alla norma ISO 19011 da tecnici esperti nel settore.<\/p>\n

Inoltre, grazie alla collaborazione con gli Organismi Notificati, offriamo supporto in qualit\u00e0 di auditor esterni per la verifica di mantenimento o di certificazione iniziale del prodotto.<\/p>\n<\/div>\n

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\u00a0If you have not found the test or service of your interest please contact our Sales Department.<\/a><\/span><\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\t

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\n\t\t\t\tTraining<\/span>\n\t\t<\/svg>\t<\/div>\n\n\t
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Biochem offers customized training plans and courses. Biochem provides you with the best multidisciplinary and skills acquired through continuous training and direct experience.<\/p>\n<\/div>\n

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Some areas of training:
\n\u25ab Validation of sterilization processes
\n\u25ab Validation of packaging
\n\u25ab How to work in aseptic
\n\u25ab Hygiene of the staff and working
\n\u25ab Check the calibration<\/p>\n

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


\u00a0If you have not found the test or service of your interest please contact our Sales Department.<\/a><\/span><\/p>\n<\/div>\n\n\t

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<\/div>\n\t<\/div>\n\n<\/div>\n\t<\/div>\n<\/div>\n\n\n<\/div>\n\t<\/div>","protected":false},"excerpt":{"rendered":"Biochem ha come obiettivo di rispondere alle crescenti e sempre pi\u00f9 complesse esigenze dei clienti offrendo un servizio professionale accurato e personalizzato. Biochem ha sviluppato negli anni una gamma di servizi, che vanno dall'affiancamento del cliente nella scelta delle analisi da eseguire all' approfondimento tecnico scientifico dei risultati ottenuti. Assistenza nella scelta delle prove Il [...]","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-78","page","type-page","status-publish","hentry"],"yoast_head":"\nTest di Emocompatibilit\u00e0 - Haemocompatibility tests | Biochem<\/title>\n<meta name=\"description\" content=\"Biochem ha come obiettivo di rispondere alle crescenti e pi\u00f9 complesse esigenze dei clienti offrendo un servizio professionale e personalizzato.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.biochem-bcm.com\/en\/servizi\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Test di Emocompatibilit\u00e0 - Haemocompatibility tests | Biochem\" \/>\n<meta property=\"og:description\" content=\"Biochem ha come obiettivo di rispondere alle crescenti e pi\u00f9 complesse esigenze dei clienti offrendo un servizio professionale e personalizzato.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.biochem-bcm.com\/en\/servizi\/\" \/>\n<meta property=\"og:site_name\" content=\"Biochem\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-22T14:41:16+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Organization\",\"@id\":\"https:\/\/www.biochem-bcm.com\/#organization\",\"name\":\"Biochem\",\"url\":\"https:\/\/www.biochem-bcm.com\/\",\"sameAs\":[],\"logo\":{\"@type\":\"ImageObject\",\"@id\":\"https:\/\/www.biochem-bcm.com\/#logo\",\"inLanguage\":\"en-GB\",\"url\":\"http:\/\/www.biochem-bcm.com\/wp-content\/uploads\/2022\/01\/logo-2.png\",\"contentUrl\":\"http:\/\/www.biochem-bcm.com\/wp-content\/uploads\/2022\/01\/logo-2.png\",\"width\":253,\"height\":58,\"caption\":\"Biochem\"},\"image\":{\"@id\":\"https:\/\/www.biochem-bcm.com\/#logo\"}},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/www.biochem-bcm.com\/#website\",\"url\":\"https:\/\/www.biochem-bcm.com\/\",\"name\":\"Biochem\",\"description\":\" Laboratorio di analisi nel settore della microbiologia e per il controllo dei dispositivi medici\",\"publisher\":{\"@id\":\"https:\/\/www.biochem-bcm.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/www.biochem-bcm.com\/?s={search_term_string}\"},\"query-input\":\"required name=search_term_string\"}],\"inLanguage\":\"en-GB\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.biochem-bcm.com\/servizi\/#webpage\",\"url\":\"https:\/\/www.biochem-bcm.com\/servizi\/\",\"name\":\"Test di Emocompatibilit\\u00e0 - 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