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

Product Inspection & Certification for Functional Safety

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 specify in the request description.

      Artificial Intelligence

      Compliance check & certification to evaluate your current management systems, processes, and product capabilities in alignment with relevant AI-related standards such as those developed by ISO SC 42: Artificial Intelligence. We ensure that your AI technologies and applications meet the safety, performance, and ethical standards critical to healthcare and medical technology, even in the absence of sector-specific AI norms. Our expertise extends to ensuring conformity with ISO 13485 (Medical Devices — Quality Management Systems) and ISO/TS 82304-2 (Health Software — Quality and Reliability).

      Supporting services to assist your team in implementing best AI practices and complying with emerging regulations such as the EU AI Act, as well as other relevant healthcare and MedTech standards. We help bridge the gap between existing healthcare compliance requirements, such as GDPR for data protection, and AI-specific standards, ensuring that your AI systems contribute safely and effectively to patient care, diagnosis, and medical device functionality.

      Training & Person Certification

      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

      CertX experts can also provide customized and in-house training to meet the your needs for qualifying your staff.

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

        See more details about our assessment process or our certification process.