MedQAIR
MedQAIR Services B.V.
Verified
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
**Who they are**
MedQAIR is a global partner specializing in medical device and AI Act compliance, offering expert consulting for market entry, regulatory affairs, and quality management systems. They are an ISO/IEC 27001:2022 certified company.
**Expertise & scope**
* Navigating complex regulatory frameworks for AI-enabled devices and Software as a Medical Device (SaMD).
* Expertise in pre-market services including Software as a Medical Device, Artificial Intelligence, Electrical Safety, Biocompatibility, Clinical Writing, and Management Systems.
* Support for post-market services such as Interim Support, Audits, Economic Operators, Vigilance Support, and Country Registrations.
* Assisting manufacturers of medical, IVD, and AI-enabled devices with regulatory compliance.
* Providing consulting to Economic Operators, including Distributors, Importers, and Authorised Representatives.
* Supporting the implementation of regulatory systems like Quality Systems (e.g., ISO 13485) and Information Security Management Systems (e.g., ISO/IEC 27001, NEN 7510-1).
* Preparation of technical documentation for submission.
**Reputation / proof points**
* ISO/IEC 27001:2022 certified.
* Proven track record of facilitating EU & US medical device and in-vitro diagnostic manufacturers.
* Office in the EU.
MedQAIR is a global partner specializing in medical device and AI Act compliance, offering expert consulting for market entry, regulatory affairs, and quality management systems. They are an ISO/IEC 27001:2022 certified company.
**Expertise & scope**
* Navigating complex regulatory frameworks for AI-enabled devices and Software as a Medical Device (SaMD).
* Expertise in pre-market services including Software as a Medical Device, Artificial Intelligence, Electrical Safety, Biocompatibility, Clinical Writing, and Management Systems.
* Support for post-market services such as Interim Support, Audits, Economic Operators, Vigilance Support, and Country Registrations.
* Assisting manufacturers of medical, IVD, and AI-enabled devices with regulatory compliance.
* Providing consulting to Economic Operators, including Distributors, Importers, and Authorised Representatives.
* Supporting the implementation of regulatory systems like Quality Systems (e.g., ISO 13485) and Information Security Management Systems (e.g., ISO/IEC 27001, NEN 7510-1).
* Preparation of technical documentation for submission.
**Reputation / proof points**
* ISO/IEC 27001:2022 certified.
* Proven track record of facilitating EU & US medical device and in-vitro diagnostic manufacturers.
* Office in the EU.
Additional information
MedQAIR assists manufacturers in streamlining their regulatory strategy, clinical planning, risk assessment, and reimbursement considerations by preparing technical documentation for submission. They focus on helping clients navigate regulatory processes faster and with greater confidence. Their services extend to supporting various types of AI techniques, including traditional machine learning, deep learning, large language models, and knowledge engineering systems. They also offer Authorised Representative and PRRC services, alongside comprehensive Medical Device & AI Quality and Regulatory Affairs Consulting.
Key Highlights
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ISO/IEC 27001:2022 certified, ensuring robust 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 devices and Software as a Medical Device (SaMD) compliance.
Source
“They specialize in navigating complex regulatory frameworks for AI-enabled devices and SaMD.”
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Offers support for both pre-market and post-market regulatory services.
Source
“Pre-market Services... Post-market Services”
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Provides consulting to Economic Operators, including Distributors, Importers, and Authorised Representatives.
Source
“provide consulting to Economic Operators (e.g. Distributors, Importers, Authorised Representatives).”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device and AI manufacturers seeking EU market entry.
- Companies needing support with SaMD and AI-enabled device compliance.
- Businesses requiring assistance with quality management systems and regulatory affairs.
How engagement typically works
- Expert consulting for regulatory strategy and market entry.
- Support in preparing technical documentation.
- Guidance on navigating complex regulatory frameworks.
Typical deliverables
- Regulatory strategy and planning.
- Technical documentation for submission.
- Quality management system implementation support.
- AI Act compliance guidance.
Good to know
- Best when requiring specialized expertise in AI and SaMD regulations.
HQ:
Amsterdam, NL
Website:
medqair.com
Public email:
info@medqair.com
Languages:
English
Timezones:
Europe/Dublin
Access:
Verified
Claim 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, assisting manufacturers of medical, IVD, and AI-enabled devices with regulatory compliance. Their team consists of recognized experts in low, medium, and high-risk medical devices, including those enabled by AI techniques. They support in implementing regulatory systems such as Quality Systems (e.g., ISO 13485) and Technical Documentation (e.g., per FDA and EU requirements). They aim to simplify market entry of safe, compliant, and innovative healthcare products and provide consulting to Economic Operators (e.g., Distributors, Importers, Authorised Representatives).
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 demo, suggesting an initial engagement process, but does not detail specific onboarding steps.
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
Yes
Supports IVDR
Yes
PRRC Qualification Summary
The website mentions PRRC services but does not detail specific qualifications of their PRRC personnel.
Regulatory Experience
The website indicates a proven track record and expertise in navigating complex regulatory frameworks for medical devices and AI, but does not specify years of experience.
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