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      gmp

      GMP, GCP, GLP and GDP Consultancy
      medical

      Medical Device
      validacion

      Validation and Qualification
      soluciones

      Solutions

      Medical Device

      The regulation of Medical Devices and Health Products enforces thoroughness in the application of the regulations and the generation of supporting documentation.

      flecha_generica

      The demanding regulatory framework for Medical Devices, currently in the process of change, requires a high level of control over all phases of the product life cycle in order to guarantee patient and user safety (design and development, Product commercialization, production, storage and distribution, installation, service and removal).

      WEBFORM: IVDR level of Compliance 

      An expert consultant from Ambti BST has created this free Webform. By filling out this multiple choice questionnaire, you will find out the level of compliance of your processes and products in IVDR. You will then receive a score and quick feedback on your needs from Ambit BST's Medical Device experts. Thus, you will be able to identify the areas for improvement and strengths of your company in this area.

      Get it 
      eqms

      eQMS

      Digital Quality Management System
      981-consultation-outline-2

      RaasDesk

      Regulatory Affairs as a Service
      ari

      ARI

      Automated Regulatory Intelligence
      gap analysis

      Gap Analysis

      Enhance your strengths and correct your weaknesses
      due intelligence

      Due Dilligence

      Identify risks and protect your business
      56-document-outline

      Regulatory &Clinical Strategy

      Implications of regulations on business

      We can help you in the following areas:

      medical-asesoria
      • Regulatory advice
        • Implementation of new regulation MDR (EU) 2017/745
        • Implementation of new regulation IVDR (EU) 2017/746
        • Medical Device Classification
        • CE marking
        • International product registration including FDA 510 (k)
        • MDSAP
        • Preliminary license to operate facilities
      • Consulting and implementation of Quality Systems according to ISO 13485 and 21 CFR 820.
      • Risk Analysis and Management according to ISO 14971.
      • Advice on the preparation of technical files.
      • Clinical evaluation.
      • Audits.
      • Equipment qualification
      • Training
      ambit_lc_medical_vf_validación
      • Software validation:
        • Software considered Medical Device
        • Software with an impact on product quality.
        • Mobile Apps

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      Ambit BST

      • Roselló i Porcel street, 21th
      • Building Meridian 8th floor
      • Barcelona 08016
      • Tel:+34 932 768 990

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