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      Medical Devices

      The demanding regulatory framework for Medical Devices, currently in a 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, marketing, production, storage and distribution, installation, service and removal)

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      • You will be able to meet all the regulatory requirements, such as:

        • Medical Device Classification
        • ISO 13485
        • Regulation update MDD > MDR & IVDD > IVDR
        • CE marking
        • Other markets  (FDA, among others)
        • MDSAP
        • Prior facility operation license

       

      We help you take your ideas to the market and accelerate a go to market in an agile, safe and lasting way.

      Our services:

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      eQMS

      Electronic Quality Management System
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      confundido

      RaaSdesk

      Regulatory Affairs As a Service
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      buscar-archivo

      ARI

      Automated Regulatory Intelligence
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      evaluacion

      Gap Analysis

      Boost your strenghts and fix your weaknesses
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      la-seguridad

      Due Diligence

      Identify risks and protect your business
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      Clinical and Regulatory Strategy

      Launch with quality, benefits and security
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      We can help you with:

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      • Consulting and implementation of Quality Systems according to ISO 13485 y 21 CFR 820
      • Risk management and analysis according to ISO 14971
      • Advice on preparation of technical files
      • Clinical Evaluation
      • Audits
      • Equipment qualification
      • Training

       

      WEBFORM: IVDR level of Compliance 

      Discover now the compliance level of your company:

       

      Fill out our webform designed by our experts to know the level of compliance of your processes and products in IVDR.

      Ver webform

      WEBFORM: Medical Devices QMS 

      ¿Want to know the maturity level of your company?

       

      Complete our interactive webform on QMS in Medical Devices (or QMS, Quality Management System) to discover the degree of maturity of your company.

       

      Ver webform

      Our partners:

      Greenlight Guru
      Dot Compliance
      Med Board
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      • Roselló i Porcel street, 21th
      • Building Meridian 8th floor
      • Barcelona 08016
      • Tel:+34 932 768 990

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