LOK Amérique du Nord fait partie d’un réseau d’excellence de professionnels, assurant une assistance ciblée pour le développement de dispositifs médicaux, gestion de la qualité, autorisations de mise en marché, opérations, service à la clientèle, sélection de sous-traitants, sélection de distributeurs et leur encadrement ainsi que les services de post-commercialisation. Ce consortium a été développé spécifiquement pour faire progresser cette industrie des technologies médicales à travers le monde.
La prestation de nos services repose sur l’établissement de relations basées sur la confiance, ainsi que sur la mise à profit des connaissances approfondies et de la grande expérience des membres de l’ensemble de l’entreprise et du réseau. Nous mettons en application nos connaissances collectives et notre expérience approfondie afin de proposer des solutions intégrées.
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LOK North America is a group of professionals helping manufacturers bring medical devices (including In Vitro Diagnostics), natural products, drugs and cosmetics to the marketplace by way of innovative and cost-effective consulting services.
We provide targeted assistance to our domestic and international clients in meeting Canadian and US regulatory, quality and clinical requirements. Start-ups, mid-size and multinational companies rely on our extensive industry experience and thorough understanding of the life science industry. We support them in the development, testing and governmental approval processes, compliance, quality assurance systems and post-marketing compliance.
Our team of experts is comprised of an impressive number of dedicated, skilled and experienced consultants, Our professionals are dynamic individuals, with diversified backgrounds; each having his/her own area of expertise. Over the years, they all have made numerous contacts within government agencies, testing labs, associations and others associated with the industry.
Company’s Keywords:
instrumentation medicale, medical devices, affaires reglementaires, regulatory affairs, analyse de risques, risk analysis, assurance qualite, quality management system, validation de logiciel, software validation, essais cliniques et precliniques, clinical & preclinical studies, homologation, clearance, cosmetiques, cosmetics, produits de sante naturels, natural products, contrat de distribution, distribution agreement, quality agreement
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