Elevate your regulatory expertise with expert-led training designed to simplify medical device compliance.
Stay ahead of evolving regulations with expert-led training on emerging technologies, risk management, and industry best practices. Gain the skills to navigate complex compliance landscapes with confidence.
Learn regulatory frameworks for AI-enabled medical devices, ensuring compliance with the EU AI Act and FDA guidelines.
Explore SaMD development, regulatory standards like IEC 62304, and strategies to ensure compliance in medical device software.
Master ISO 13485 QMS principles, regulatory tools, and strategies to ensure compliance and enhance medical device quality.
Understand ISMS frameworks like ISO/IEC 27001 to protect sensitive patient data and ensure regulatory compliance in healthcare.
Navigate MDR and IVDR regulations, covering clinical evaluation, risk management, and post-market surveillance for EU compliance.
Learn cybersecurity strategies to manage medical device vulnerabilities, implement effective threat modeling, and ensure regulatory compliance.
Develop auditing skills for internal processes, clinical evaluations, and compliance audits to drive continuous improvement in healthcare.
Gain industry-leading insights with structured, interactive courses designed to simplify regulations, enhance compliance, and drive industry best practices.
CEO, Co-Founder
A medical device industry professional with 16+ years of expertise in regulatory affairs & quality management, specializing in AI medical devices.
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.
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 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.
Regulatory & Quality Expert
Experienced in complex MedTech product development, driving compliance from early strategy to market launch across medical devices, IVDs, MDSW, and AI-based 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.
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