Your compliance partner in Digital Healthcare

As a first step, it is important to document what your product will be used for carefully (its ‘intended purpose’ or ‘intended use’ and ‘indications for use’), and what claims will be associated with the product. Based on that information, it is highly recommended to document a regulatory strategy, assess whether local legislation may apply to the product, and determine how the product is classified under such legislation (‘product qualification and classification’).

The landscape of digital legislative frameworks is becoming increasingly complex, and often more than one legislative instrument may apply. For example, in the European Union, a product may qualify as a medical device (SaMD, SaIVD, SAIeMD), and or artificial intelligence system (potentially being High-Risk), and be subjected to medical device legislation (MDR 2017/745 or IVDR 2017/746), artificial intelligence legislation (AI Act 2024/1689) and healthcare interoperability legislation (EHDS 2025/327).

The applicable legislation may be supported by various standards and guidance documents, which set out further requirements applicable to the product.

Having a thorough understanding of all these aspects is important prior to the start of the development of a product, to ensure that by the end of the development process, all regulatory requirements have been met.

The European Union is today our home market, where we maintain close contact with Notified Bodies, and especially those that are experienced in the field of SaMD’s and SaIVDs.

However, we do have significant expertise in other regulatory jurisdictions too, especially in the field of software as a medical device (SaMD, SaIVD). We have supported multiple types of FDA submissions throughout our individual careers, such as Pre-submissions, 510(k)’s, 510(k)’s subject to special controls, such as reader-studies (MRMC), De Novo applications, PMA submissions, and 513(g)’s.

We have also performed applications in other regulatory jurisdictions and supported the implementation of MDSAP-compliant management systems.

Digital healthcare solutions, and especially Artificial Intelligence-enabled medical devices (AI/ML-enabled medical devices) require extensive post-market surveillance activities. These technologies can have a direct, but more often an indirect impact on the health and safety of human beings. Implementation of robust post-market surveillance and post-market monitoring systems is crucial to detect abnormal behaviour, which may have several causes, such as but not limited to performance drift. Similarly, it is important to monitor the security of products after they have been released onto the market.
This applies not only to medical devices and in vitro medical devices, but also applies to Artificial Intelligence systems. Similarly, all other digital products are subject in Europe to the Cyber Resilience Act (2024/2847).

Other services we can support companies with are their EUDAMED registration process, continued Management System improvement processes (e.g., audits, due diligence activities, interim PRRC and DPO roles, etc).

Simply put, MDIS is a smart document sharing platform. It allows organizations to drastically reduce duplicate efforts in keeping interested parties informed on documentation relevant to their organization.

As an example, medical device distributors must, per MDR and IVDR article 14 receive and verify parts of the technical documentation, such as the accompanying information (i.e., the Instructions for Use). Individual alignment with each manufacturer, and obtaining the latest version of documentation with each manufacturer may be a time-consuming task. Instead of aligning with each individual distributor, the manufacturer simply uploads their documentation once and can share it with all their interested parties in a single action. Verification of the documentation is automatically logged within the system to support compliance.

The system tracks both at the Basic UDI and UDI-DI level, and further includes the option to generate automated exports for entering into EUDAMED, where manual entry into EUDAMED will no longer be required. In due time, we aim to integrate other databases such as Swissdamed, GUDID, UK databases, etc.

We offer Quality, Regulatory, and Information Security services to the full Economic Operator Chain as defined within legislation. In addition, our MDIS solution can be used by any Economic Operator too, as it is intended to connect Economic Operators to one another.

You can request a consultation with the MedQAIR team members by reaching out through our MedQAIR contact page or by emailing us via the contact information provided on the website.

A regulatory expert will follow up to understand the specific needs and propose next steps.