Who We Are
We are a reliable medical device consulting company offering expert support in Authorised Representative services, PRRC services, and Medical Device & AI Quality and Regulatory Affairs Consulting.
We are a reliable medical device consulting company offering expert support in Authorised Representative services, PRRC services, and Medical Device & AI Quality and Regulatory Affairs Consulting.
A reliable and reputable medical device and artificial intelligence compliance consulting company with a proven track record of facilitating EU & US medical device and in-vitro diagnostic manufacturers. 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).
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.
We can support in implementing regulatory systems such as Quality Systems (e.g. ISO 13485), Information Security Management Systems (e.g. ISO/IEC 27001, NEN 7510-1), Technical Documentation (e.g. per FDA and EU requirements).
“As regulatory compliance experts, our mission is to simplify market entry of safe, compliant and innovative healthcare products”
CEO, Co-Founder
To be a reliable compliance partner for global market access for economic operators from the early pre-market stages up to product decommissioning.
Foster trust, reliability and transparency within the healthcare community by ensuring market entry of safe and compliant medical devices.
We prioritise efficiency and transparency aiming to be the trusted partner for the full chain of economic operators within the healthcare industry.
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.
Accessing the EU markets through a specialized medical device consulting company is ideal and efficient. The experts in medical device regulation at MedQAIR ensure simplified entry and ongoing compliance of your medical, in-vitro diagnostics, and AI-enabled and stand-alone AI devices in European markets. As a seasoned medical device consulting company, we act as a dependable European Authorised Representative (EU AR/EC REP) and PRRC for manufacturers lacking a registered office in the EU.
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