Quality at MDsim: More Than Just a Standard 

At MDsim, quality is more than just a checkbox: it is the heartbeat of everything we do. Why is it so important? Because our dedication to quality ensures that every surgeon using our platform feels supported by tools they can trust. 

“When we first set out to build this company, we made a deliberate choice: start from quality” explains Dany Assaker, co-founder of MDsim and VP of Quality & Regulations (Q&R). “Establishing a robust Quality Management System (QMS) was one of our first steps. In the world of Software as a Medical Device (SaMD), this is not optional: it is essential.” 

Indeed, to commercialize a medical device, regulatory approvals such as FDA clearance in the U.S. or the CE mark in Europe are required. Having a strong QMS is a fundamental part of achieving these authorizations.  

Early this year, MDsim reached an important milestone by obtaining the ISO 13485 certification, the internationally recognized standard that validates the robustness of our QMS. It also underscores our commitment to quality in everything we do.  

A Quality Policy That Drives Us  

Our goal is simple: deliver exceptional software and services, grounded in ethics and a culture of continuous improvement. MDsim’s quality policy reflects this view: 

“Our commitment is designing, developing, deploying, maintaining and supporting high quality, industry-leading software and services to assist healthcare providers in enhancing patients’ condition. The quality of our deliverables to stakeholders is based on the highest standards of ethics and professionalism, combined with a continuous improvement culture; the latter includes the compliance with the quality management system and the maintenance of its effectiveness.” 

Quality Objectives 

At MDsim, we set clear objectives to make sure we live up to our words. Here’s what keeps us focused: 

• Customer Satisfaction.  

• Qualified Team.  

• Efficient & Effective Products.  

• Excellent Technology.  

• Innovative Culture.  

• High-End Stakeholders. 

• Continuous Improvement.  

• Ethical Behavior.  

• Commitment to ESG.  

• Regulatory Compliance.  

Our quality policy and quality objectives are what allows us to innovate and keep the trust of healthcare professionals who rely on us.  

Stay tuned for more updates as we are in the process of obtaining regulatory approvals and expand our impact in spine care.