medical devices development & operations

medical devices design and development services, including QMS software ISO13485 based.

medical devops ERP contact

Automated Bone Drilling System

Machine learning approach with real-time 3D tracking

medical device manufacturer ERP software

medical devops ERP covers your specific needs as designer, manufacturer or distributor.

manufacturing control

Streamline medical device manufacturing with integrated ERP-PLM software. Control production workflows, ensure compliance, and optimize operations from design to delivery

medops ERP

quality management

Comprehensive quality management systems for medical device manufacturers. Ensure FDA compliance, streamline audits, and maintain ISO standards with integrated QMS.

medops ERP

regulatory

Streamline medical device regulatory processes with automated compliance software. Manage FDA submissions, CE marking, and global regulatory requirements efficiently

medops ERP

medical technology

Innovative healthcare technology solutions including diagnostic systems, surgical instruments, and monitoring devices. Our products are designed to improve patient outcomes while meeting the highest standards of safety and efficacy.

Diagnostic Systems

Advanced diagnostic equipment for accurate medical assessments

surgical instruments

automated bone drilling system - a machine learning approach by real time 3d tracking

orthopedics

advanced robotic prosthesis

med tech projects

We collaborate with medical device design teams and medtech startups worldwide, contributing our capabilities in electronic, mechanical, and medical device management software development for both large diagnostic imaging systems, IVD devices, and surgical or orthopedic equipment. Our expertise includes Software as Medical Device (SaMD) development with integrated quality management systems.

We operate under our ISO 13485 quality management system or adapt to our client's requirements, ensuring maximum safety, complete traceability, and efficacy in bringing medical devices to market. Our medical device management software ensures regulatory compliance with FDA 510(k), CE marking, and IEC 62304 standards for Software as Medical Device applications.

medical devices
medical technology improving people quality of life