Critical Software
Critical Software
Critical Software
Critical Software
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A few clients

Unimed
Medtronic
Coimbra Genomics
Centro Hospitalar e Universitário de Coimbra

Unimed

Our solutions for the
healthcare industry

RAMS & Certification Support

We drive safety in medical devices by helping our clients meet industry requirements in a cost-efficient way.

  • We ensure our clients are compliant with the relevant applicable medical device standards like IEC 62304, IEC 82304-1, ISO 14971, ISO 13485 and IEC 60601. Our services include:
  • Project gap analysis: identifying gaps with respect to safety requirements and determining the best way to overcome them, given specific project and client needs.
  • Safety management & safety case preparation: managing functional safety across the medical device development lifecycle, including dealing with safety cases.
  • Independent Safety Assessment (ISA): compiling and reviewing all project safety artefacts to assess compliance with applicable regulation.

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Related News

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7 Top Tips to Deal with the New MDR (Without the Stress!)

We are less than six months away from some significant changes in the medical devices market.

7th January 2020
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The Medical Devices Regulation Is Coming! Are You Ready?

Thousands of health apps and devices that use software are available in the market without rigorous checks. Fortunately for everyone’s safety, the Medical Devices Regulation 2020 is coming to improve industry standards.

19 November 2019
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Medical Software – The Case for New Regulation

Continued scientific and technical developments have pushed the medical devices industry to the point of big change. What now?

23rd September 2019
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