Get to know the people shaping compliance at MedQAIR – regulatory consultants, quality managers, and innovators working closely with clients to simplify and secure market access.
Meet the MedQAIR team! experts simplifying compliance and securing market access.
CEO, Co-Founder
A medical device industry professional with 16+ years of expertise in regulatory affairs & quality management, specializing in AI medical devices.
Regulatory & Quality Expert
Experienced in complex MedTech product development, driving compliance from early concept through market launch and beyond.
COO, 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.
Principal Consultant
A healthcare informatics expert with 30+ years’ experience in software, quality, and regulatory affairs across medical devices, IVDs, AI, and clinical IT.
Consultant
Experienced in EU-MDR and global MedTech regulations, driving strategy and approvals across markets and therapeutic areas.
Consultant
A seasoned Software as a Medical Device (SaMD) expert, combining regulatory know-how with hands-on software development experience.
Jr. Quality & Regulatory Consultant
Biomedical Sciences graduate supporting quality and regulatory activities with experience in data integrity, documentation, and research processes.
Business Development Executive
With 20+ years in economic development, including 10 at CRDA, Mike now leads Graney LLC, advising clients like MedQAIR. He specializes in FDI, life sciences, and transatlantic investment.
Co-Founder
An agile entrepreneur and venture builder, skilled in building IT solutions and remote teams across the globe.
Chief Advisor
An independent strategic advisor with 25+ years of senior leadership experience, guiding companies through complex transitions and growth.
Regulatory Expert
Regulatory affairs consultant with expertise in healthcare, focusing on quality and compliance for medical devices and combination products.
Regulatory Expert
Pragmatic medical device consultant with 35+ years of experience in regulatory compliance and quality management systems.
Regulatory Expert
Susan is a global MedTech expert, guiding manufacturers through complex regulations across the US, EU, and emerging markets.
QA & RA Consultant
A medical device expert with 10 years of experience in SaMD and AI/ML, driving innovation and compliance in healthcare technology.
Tech Expert
With a sharp eye for detail and strong problem-solving skills, Sanjay is dedicated to building robust, scalable technology solutions.
Digital Marketing Manager
An expert Digital Marketing Manager & Strategist skilled in digital marketing campaigns, lead generation, and brand growth.
Content Lead
An experienced content specialist crafting compelling, high-quality content across formats to connect with diverse audiences.
Find answers to common questions about our services, compliance processes, and how we can assist your business.
No. When you invite a manufacturer, they can join at no cost. They only need a paid plan if they want to use MDIS independently.
If a manufacturer is already using MDIS with another partner, connecting to them is instant because the shared device workspace is already structured.
Declarations of conformity, CE marking status, labeling materials for your region, UDI data, and certificates. Manufacturers control what each partner sees.
MDIS keeps the visible device workspace and document context organised in one place so your team can review what is relevant without rebuilding the picture from multiple systems.
MDIS runs on ISO/IEC 27001 certified infrastructure. Documentation is stored with role based access so distributor teams work from the records made visible to them.
Email works until it does not. Documents get lost, versions become outdated, and teams stop trusting which file is current. MDIS replaces that with a controlled, traceable device workspace.
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