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)

  • 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:



Electronic Quality Management System
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Regulatory Affairs As a Service
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Automated Regulatory Intelligence
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Gap Analysis

Boost your strenghts and fix your weaknesses
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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:

  • 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.


Complete webform

Our partners:

Greenlight Guru
Dot Compliance
Med Board

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