Digital Health & Pharmaceuticals

Digital technologies are integral to daily life and there is immense scope for use of digital health solutions and automation. While these new fields of application bring benefit they are also bringing new challenges, in 2 domains: 


  • Cyber security: To protect the privacy and integrity of patient and other criticial data and the security of critical connected devices to avoid them being hacked or remote controlled.

  • Functional Safety: Operational safety of automated devices such as e.g. ICUs, insulin pumps, pace makers, and the application of neural networks in controlling those devices or as support for the medical teams in image scan (e.g. cancer detection) or similar areas regarding their safe and reliable operation

CertX may help you in evaluating and mitigation those risk in all those areas.

Applications and medical equipments need to take care of the security of sensitive data and critical equipment like ICUs must not be hacked, remote controlled or shut down.

CODEMA Protocols

Ensuring and maintaining security and privacy in the pharmaceutical sector with specific or tailor made pharmaceuticals is probably one of the most important and but also most challenging subjects.

In order to get your company processes and setup ready to ensure compliance to the latest regulation Codema has developped a set of protocols ensureing your processes and used tools and service provider are prepared and maintained.


Standardising criteria of evaluation is a key element in the CODEMA PHARMA approach (more details at the links below).



We offer the for each protocol 2 different levels of evaluation:

  1. Gap Analysis: This is based on a self assessment being evaluated by our experts incl. a remote pre-audit. You will receive a report defining areas of compliance and non-complianecs (if any), as well as recommendations for improvements.
  2. Certificate: Our experts will run through the protocol in an audit (on-site or remote) to evaluate independently the implementation of the protocols in your managements system and processes.

A gap analysis can be done standalone. For a certificate stage 1 and 2 as defined above are required. More info on the generic management system certification process please see here and more details on the the Codema Protocols can be found here.

In case of further details or a quote requested, please contact us via the project request form below. For a quotation we would need the number of employees and number of different sites, which you may specifiy in the request description.

Votre demande de projet - contactez-nous

Veuillez remplir le modèle ci-dessous pour toute demande que vous pourriez avoir. Laissez les champs vides si vous n'êtes pas sûr ou si vous ne pouvez pas fournir l'information. Nous serons heureux de vous recontacter et de trouver les informations nécessaires lors d'un appel ou d'une vidéoconférence.

    Pour vous mettre en contact avec le bon expert, vous pouvez préciser le service ou la demande. Si vous n'êtes pas sûr, laissez le champ libre et nous vous contacterons rapidement.

    Pièces jointes telles que des documents de projet ou d'autres informations pertinentes si elles sont jugées utiles.
    (Type de fichier : pdf, docx, doc, xls, xlsx, ppt, pptx / Taille limite : 20 MB)

    Avis de non-responsabilité :
    En tant qu'organisme de certification et d'inspection accrédité, nous sommes tenus au secret professionnel, qu'un accord de non-divulgation ait été conclu ou non. Vos données seront traitées avec le plus grand soin et supprimées à votre demande.

    Formation et certification des personnes

    CertX provides a dedicated person certification program at different level of expertise for responsibilities for safety management related to IEC 62443 (operational cyber security) or ISO 13845 (QMS for medical devices)

    We also offer in combination with Medidee introductory and overview trainings

    Les experts CertX peuvent également fournir des formations personnalisées et internes pour répondre à vos besoins de qualification de votre personnel.

    See more details about our qualification scheme at our training & person certification process page

      T +41 26 309 29 99