Quality Driven Approach
Medioh places quality front and center to ensure patient safety in all performed activities. Medioh’s facilities are ISO 13485 compliant, following current Good Manufacturing Processes (cGMP) and Good Documentation Processes (GDP).
Quality Assurance and Regulatory Compliance
Medioh’s comprehensive quality management system is meticulously crafted to guarantee that your program not only meets but exceeds all the stringent regulatory standards established by the FDA and Health Canada. We diligently support essential aspects like DMR (Device Master Record) and DHR (Device History Record) to ensure seamless compliance. Our strength lies in offering customized workflows tailored to your unique needs and objectives. We enforce these workflows with the utmost precision using our proprietary software, leaving no room for errors. Additionally, our commitment to data security extends to system integration, ensuring the safe transfer of critical information. With Medioh, you can trust in a quality management system that prioritizes regulatory excellence and operational efficiency.