Who We Are

MedQAIR is a regulatory consultancy supporting manufacturers of digital health products through pre-market and post-market compliance across EU and US jurisdictions. The team works with manufacturers of SaMD, SaIVD, AI/ML-enabled medical devices, high-risk AI systems, and EHR systems on regulatory strategy, technical documentation, quality management, cybersecurity, and submission support under MDR 2017/745, IVDR 2017/746, AI Act 2024/1689, EHDS 2025/327, and CRA 2024/2847.

MedQAIR provides end-to-end regulatory and quality compliance support for medical devices, IVDs, and AI-enabled health technologies across EU (EU MDR, IVDR), US ( FDA), and global jurisdictions. Services cover both pre-market and post-market phases, tailored to traditional, software-based, and AI-enabled devices.

Pre-Market Support

MedQAIR supports market entry with regulatory documentation and compliance for:

• Regulatory Strategy Building
• Cybersecurity and Privacy
• Data Management and Governance
• Software Lifecycle Management
• Management Systems
• Global Market Registrations

Post-Market Support

MedQAIR helps stay compliant through:

• Economic Operators
• UDI support in EUDAMED and GUDID
• Audits
• Post-market follow-up
• Interim Support (DPO, PRRC, QA/RA, Security)
• Regulatory due diligence

MedQAIR supports manufacturers, authorised representatives, and other economic operators in meeting the regulatory obligations set out in the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). This includes both pre-market and post-market activities required to maintain compliant access to the European market.

Key areas of support include:

• Authorised Representative (AR) Role
• Person Responsible for Regulatory Compliance (PRRC)
• Regulatory Strategy & Documentation
• EUDAMED Registration & UDI Management
• Vigilance & Post-Market Surveillance
• Software and AI-Enabled Devices

Through a structured, standards-based approach, MedQAIR enables manufacturers to confidently meet EU market requirements, avoid costly delays, and maintain compliance throughout the product lifecycle.

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.

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.

MedQAIR was co-founded by Leon Doorn and Ivo Flipse, both with over 15 years of regulatory affairs experience in digital health and medical device software. The company is advised by Willibrord Driessen, founder of Qserve Consultancy and a recognised authority in EU regulatory compliance. The software development of MDIS, MedQAIR’s document-sharing platform, is led by Hugo Messer and Jeroen van Duffelen.

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.

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.

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 are 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).

The intended purpose and indications for use you document at the start determine which regulations apply, how the product is classified, and what evidence you need to reach the market. Changing these later means reworking documentation, retesting, and in some cases redesigning the product. Starting with a clear regulatory strategy keeps development aligned with what regulators will expect.

Yes. Guidance documents, harmonised standards, common specifications, and regulatory interpretations continue to evolve. The AI Act, EHDS, and CRA are still being implemented, with delegated acts and technical specifications expected over the coming years. Regulatory strategy is an ongoing process, not a document produced once at the start.

Yes. Guidance documents, harmonised standards, common specifications, and regulatory interpretations continue to evolve. The AI Act, EHDS, and CRA are still being implemented, with delegated acts and technical specifications expected over the coming years. Regulatory strategy is an ongoing process, not a document produced once at the start.

MedQAIR works across the full range of digital health product types: software as a medical device (SaMD), software as an in vitro diagnostic (SaIVD), AI/ML-enabled medical devices, high-risk AI systems, electronic health record (EHR) systems, wellness applications, and other healthcare software such as hospital operational tools. Each product type carries distinct regulatory obligations, and the applicable frameworks are identified as part of every engagement.