OUR EXPERTISE
Technical Documentation
We assist in compiling, reviewing, and updating technical files for medical devices, medical device software, and in vitro diagnostic devices.
Quality Management Systems
Our services include building, auditing, and updating quality systems for manufacturers, distributors, and importers in compliance with standards like ISO 9001, ISO 13485, ISO 14001, GLP, GDP, GMP, and IEC62304.
Clinical Evaluation Reports
We compile comprehensive Clinical Evaluation Reports, integrating clinical trials, product requirements, and presenting equivalence and state of the art comparisons.
Outsourced Quality Management
We offer services as an outsourced quality manager, handling intricate quality management tasks.
Regulatory Interpretation
Our team is adept at interpreting MDR and IVDR regulations and documenting them on behalf of our clients.
Staff Training
We provide training for company staff on quality and regulatory topics, ensuring they are up to date with the latest standards.
Production Process Validation
Our services extend to validating production processes to ensure compliance and efficiency.
Project Management
We manage product design projects, ensuring they align with regulatory requirements.
Software Solutions Development
Our expertise includes developing software solutions and interpreting regulatory requirements.
OUR APPROACH
We focus on providing comprehensive, cost-effective, and flexible solutions. Our team, with extensive experience in digital health solutions development, ensures that your products not only meet regulatory standards but also excel in quality management.
