MedQAIR
MedQAIR Services B.V.
MedQAIR is a global partner for medical device and AI Act compliance, offering expert consulting for market entry, regulatory affairs, and quality management systems. They specialize in navigating complex regulatory frameworks for AI-enabled devices and SaMD.
MedQAIR is a leading medical device consulting company specializing in regulatory compliance and quality management for both medical devices and Artificial Intelligence (AI) solutions. They offer comprehensive services including Authorised Representative and PRRC support, assisting manufacturers in navigating complex regulatory landscapes for EU & US market access, as well as other global jurisdictions. Their expertise extends to AI-enabled devices, including those utilizing machine learning, deep learning, and large language models. MedQAIR helps streamline regulatory strategy, clinical planning, and technical documentation preparation for submissions. They are also experienced in Software as a Medical Device (SaMD) and Software in Medical Devices (SiMD), guiding clients through evolving digital health regulations. With an ISO/IEC 27001:2022 certification, MedQAIR ensures robust information security across their services. They support the implementation of regulatory systems like Quality Systems (ISO 13485) and Information Security Management Systems (ISO/IEC 27001). Their mission is to simplify market entry for safe, compliant, and innovative healthcare products, acting as a trusted partner for economic operators throughout the product lifecycle.
About
**MedQAIR** is a global partner for medical device and AI Act compliance, offering expert consulting for market entry, regulatory affairs, and quality management systems. They specialize in navigating complex regulatory frameworks for AI-enabled devices and SaMD.
- **Who they are**
MedQAIR is a medical device consulting company based in the EU, providing expert support for regulatory compliance and market access. They are ISO/IEC 27001:2022 certified, demonstrating a commitment to robust information security.
- **Expertise & scope**
* Medical Device Regulation (MDR) and AI Act compliance
* Software as a Medical Device (SaMD)
* Artificial Intelligence (AI) enabled devices, including machine learning, deep learning, LLMs, and knowledge engineering systems
* Quality Management Systems (e.g., ISO 13485)
* Technical Documentation preparation for EU and FDA requirements
* Pre-market services including regulatory strategy, clinical planning, and risk assessment
* Post-market services such as In-Country Representation, Interim Support, Audits, Economic Operator support, Vigilance Support, and Country Registrations
* Consulting for manufacturers of medical, IVD, and AI-enabled devices
* Support for Economic Operators like Distributors, Importers, and Authorised Representatives
- **Reputation / proof points**
* ISO/IEC 27001:2022 certified
* Offices in the EU
- **Who they are**
MedQAIR is a medical device consulting company based in the EU, providing expert support for regulatory compliance and market access. They are ISO/IEC 27001:2022 certified, demonstrating a commitment to robust information security.
- **Expertise & scope**
* Medical Device Regulation (MDR) and AI Act compliance
* Software as a Medical Device (SaMD)
* Artificial Intelligence (AI) enabled devices, including machine learning, deep learning, LLMs, and knowledge engineering systems
* Quality Management Systems (e.g., ISO 13485)
* Technical Documentation preparation for EU and FDA requirements
* Pre-market services including regulatory strategy, clinical planning, and risk assessment
* Post-market services such as In-Country Representation, Interim Support, Audits, Economic Operator support, Vigilance Support, and Country Registrations
* Consulting for manufacturers of medical, IVD, and AI-enabled devices
* Support for Economic Operators like Distributors, Importers, and Authorised Representatives
- **Reputation / proof points**
* ISO/IEC 27001:2022 certified
* Offices in the EU
Additional information
MedQAIR assists manufacturers in streamlining their regulatory strategy and preparing technical documentation for submission. They focus on navigating complex regulatory frameworks, particularly for AI-enabled medical devices and SaMD. Their services extend to supporting Economic Operators, offering a comprehensive approach to market entry and ongoing compliance within regulated markets like the EU and US. Buyers can expect guidance on quality systems, risk management, and pre-market activities, aiming to accelerate the path to market for safe and compliant healthcare products.
Key Highlights
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ISO/IEC 27001:2022 certified for information security.
Source
“Our organisation is ISO/IEC 27001:2022 certified, ensuring robust and continuously improved information security across our advisory services and platforms.”
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Specializes in AI-enabled medical devices, including machine learning, deep learning, LLMs, and knowledge engineering systems.
Source
“Our team consists of recognized experts in both low, medium and high risk medical devices, including devices that are enabled by artificial intelligence (AI) techniques such as traditional machine learning, deep learning, large language models and knowledge engineering systems.”
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Offers comprehensive support for Economic Operators, including Distributors, Importers, and Authorised Representatives.
Source
“We can also support other regulatory jurisdictions for medical & in-vitro diagnostic devices, and provide consulting to Economic Operators (e.g. Distributors, Importers, Authorised Representatives).”
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Provides both pre-market and post-market regulatory services.
Source
“Pre-market Services... Post-market Services”
Certifications & Trust Signals
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ISO/IEC 27001:2022 certified.
Source
“Our organisation is ISO/IEC 27001:2022 certified, ensuring robust and continuously improved information security across our advisory services and platforms.”
Buyer Snapshot
Best for
- Medical device and AI Act compliance consulting
- Navigating complex regulatory frameworks for AI-enabled devices
- Support for market entry and regulatory affairs
How engagement typically works
- Expert consulting
- Streamlining regulatory strategy
- Preparing technical documentation
Typical deliverables
- Regulatory strategy guidance
- Technical documentation
- Quality Management System implementation
- Market access support
Good to know
- Best when seeking specialized expertise in AI medical devices and SaMD compliance.
HQ:
Amsterdam, NL
Languages:
English
Timezones:
Europe/Dublin
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
US, GB, CH, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–21 days
Pricing model:
Retainer
Starting from:
EUR 1,800
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
PRRC Qualification Summary:
MedQAIR offers PRRC services as part of their comprehensive medical device and AI compliance consulting. Their team consists of recognized experts in low, medium, and high-risk medical devices, including those enabled by artificial intelligence techniques such as traditional machine learning, deep learning, large language models, and knowledge engineering systems. They support manufacturers in navigating regulatory requirements and ensuring market access for safe and compliant healthcare products.
eudamed_onboarding_support
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
The website mentions booking a free consultation and a free MDIS demo as initial engagement points.
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Device Classes Supported
Low, medium, and high risk medical devices
Supports MDR
true
Supports IVDR
true
PRRC Qualification Summary
Expertise in PRRC services for medical devices and AI Act compliance.
Regulatory Experience
Expertise in medical device and AI Act compliance, market entry, regulatory affairs, quality management systems, and technical documentation for EU and FDA requirements.
