Meet the Founders #2: Leon Doorn
MedQAIR’s Journey: Founding Story, Mission, and What Sets
March 25, 2025
Ready for effortless compliance?
Meet MDIS – Your All-in-One Medical Device Compliance Platform
Regulatory and Quality compliance in design and development is complex. We help you streamline regulatory strategy, clinical planning, risk assessment, and reimbursement considerations by preparing technical documentation for submission.
With a MedQAIR expert on your team, you can navigate these processes faster with greater confidence.
To learn more about our expertise and services, browse our menu on the left.
To find out more about our areas of expertise of services, browse our menu below.
Software can be stand-alone (SaMD) or embedded in a medical device (SiMD). We can help you to navigate a continuously evolving and increasingly complex regulatory framework around digital health solutions.
Our experts are experienced in bringing software devices onto the market and understand complexities around cybersecurity, risk management, and software lifecycle management.
Artificial Intelligence (AI) is increasingly used in medical devices. AI-enabled medical devices (AIaMD) add additional challenges to software medical devices.
We have years of experience in bringing AI-enabled medical devices onto the market. We are fully up to speed on the latest European regulations and the FDA guidelines.
Devices powered by an energy source are required to meet a large number of regulatory requirements, including those for essential safety and performance. Most of the requirements derive from the IEC 60601 standard series.
We can support you to assess which of these requirements apply to your device, and select the relevant tests to be completed to demonstrate electrical safety, including the relevant EMC tests.
Medical devices that come into contact with a patient, directly or indirectly, must ensure that the materials are biologically safe. To ensure biocompatibility, manufacturers must execute tests per the ISO 10993 standards.
We can support from the initial material selection stages, execution of biological safety risk assessments, up to the selection of the relevant tests, and summarising the test execution for regulatory submission to authorities.
Nearly all medical devices must be supported by a level of clinical data, whether generated by the manufacturer or based on literature. The manufacturer must assess the State-Of-The-Art (SOTA), and determine the level of clinical evidence required for market entry.
Our team can support each of these stages, by establishing the SOTA, determining the need to obtain clinical data, and support in setting up a clinical study protocol, where needed, and writing up the clinical evaluation.
A Management System can be implemented for various purposes, e.g. for Quality Management or Information Security Management. Such systems support regulatory compliance under various regulations such as medical devices, artificial intelligence, and privacy and information security.
We have significant expertise in implementing Management Systems, and combinations of Management Systems, such as for Quality (per ISO 13485) and Information Security (per ISO/IEC 27001 and NEN 7510-1).
Once your medical device is on the market, you will need to implement Post Market Surveillance & Clinical Follow-up strategies. As your device gains traction, you may also consider global expansion.
MedQAIR is here to support you once your medical device has entered its first market(s).
To learn more about our expertise and services, browse our menu on the right.
To find out more about our areas of expertise of services, browse our menu below.
When bringing medical devices into unknown territories, manufacturers often need to appoint a local representative (e.g. a European Authorised Representative). The representative can support from a regulatory perspective to interact with authorities.
We support you as a European Authorised Representative, and with our partners, we can further support you as a US Agent, UK Responsible Person, and Swiss Authorised Representative.
Our team can provide interim support for key roles, including Data Protection Officer (DPO), Person Responsible for Regulatory Compliance (PRRC), and Quality/Regulatory/Information Security experts.
We can support business continuity by offering hands-on guidance in regulatory compliance, risk management, and cybersecurity.
To promote continuous improvement, execution of audits is of crucial importance to any Management System. This can include internal audits, supplier and subcontractor audits, due diligence audits, FDA mock audits, MDR / IVDR quality system audits, ISO 13485, ISO/IEC 27001 and NEN 7510-1 audits, and external audits by certification bodies.
At MedQAIR we can support in executing audits, and in guiding you through external certification audits.
Regulatory compliance is not limited to the manufacturer, it extends to Importers, Distributors, Authorised Representative, repackers, and relabelers.
Our software solution, MDIS supports economic operators along the full chain in meeting and demonstrating all their regulatory requirements in a single platform. We support automation of registration in regulatory databases (such as EUDAMED).
Once a device is on the market, valuable information is collected from post-market stages. This may include unexpected adverse events, which may need to be reported to the regulatory authorities.
Our experts are ready to support you in evaluating the need to report such events to regulators such as competent authorities or the FDA. Our MDIS solution supports capturing the relevant information, including the IMDRF codes.
Bringing medical devices into new regulatory jurisdictions can be challenging, unknown challenges may arise, and additional data may be required to complete the registration process.
We can support you with your medical device registrations. Reach out to us to understand what local regulatory requirements entail and what requirements must be met.
A leading Medical Device compliance company supporting Pre- & Post-Market phases, including EAR and PRRC services.
To market medical devices and in-vitro diagnostics in the European Union, it is mandatory to have a designated PRRC.
Confidently place your devices on the EU market by partnering with an experienced Authorised Representative.
Experts with deep knowledge of EU compliance frameworks ensure swift regulatory approval for your devices across EU territories.
Our efficient and streamlined approach to compliance helps minimise time-to-market and ensures a smooth regulatory approval process.
We understand the contents of the Artificial Intelligence (AI) Regulation and can support you to demonstrate compliance with the regulation, both stand-alone and when embedded in a Medical Device or IVD.
You can trust us to handle all aspects of your medical device and IVDR compliance with professionalism and integrity.
Dedicated in-house regulatory strategists and local affiliates who assist with preparing, registering, and maintaining regulatory data in EUDAMED.
Our expert team of PRRC for medical and IVD devices ensures organisational compliance with regulations and verifies device conformity according to QMS standards.
Assistance with ISO 13485:2016 certification, gap analyses of source documents, internal mock audit support, and help with remediation plans.
A knowledgeable team that stays updated on the latest regulatory changes, ensuring compliance with evolving requirements.
CEO, Co-Founder
A medical device industry professional with 16+ years of expertise in regulatory affairs & quality management, specializing in AI medical devices.
co-founder
An SaMD expert with 15+ years of experience specializing in MDR, and FDA compliance with a focus on cybersecurity and software lifecycle management.
Co-Founder
An agile entrepreneur and venture builder, skilled in building IT solutions and high-end consultancy services. Passionate about enabling investors to achieve impact + ROI.
Chief Advisor
An independent strategic advisor with 25+ years of senior leadership experience, focusing on Medical Device compliance globally.
Regulatory Expert
Experienced regulatory affairs consultant in the healthcare industry, specializing in quality systems for medical devices. Authored numerous guidelines and standards for medical technology quality and risk management.
Regulatory Expert
Pragmatic medical device consultant with 35+ years of experience in regulatory compliance, quality management, auditing, and training, ensuring safe and effective medical devices worldwide.
Regulatory Expert
Susan, VP of International Regulatory Affairs at Qserve, is a global MedTech expert, guiding manufacturers through complex regulations to ensure market access and compliance.
QA & RA Consultant
A digital health expert with over 8 years of experience in regulatory and product management, driving innovative medical software to market.
QA & RA Consultant
A seasoned Software as a Medical Device (SaMD) expert, combining regulatory knowledge & AI innovation to deliver compliant medical software solutions.
QA & RA Consultant
A medical device expert with 10 years of experience in SaMD and AI/ML, driving innovation and guiding clients through regulatory approval.
Tech Expert
With a sharp eye for detail and strong problem-solving skills, Sanjay is dedicated to ensuring the optimal performance of our online presence.
Digital Marketing Manager
An expert Digital Marketing Manager & Strategist skilled in digital marketing campaigns and & Customer Experience Management (CX).
Content Lead
An experienced content specialist crafting compelling, high-quality content across various platforms with meticulous attention to detail.
Senior Digital Marketer
A competent digital marketing professional with a flair for innovation and driving successful campaigns.
Explore our blog posts on MDR, IVDR, and AI Act compliance to stay ahead of regulatory changes.
MedQAIR’s Journey: Founding Story, Mission, and What Sets
The International Organization for Standardization (ISO) is preparing
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