Quality Systems
Take your medical product development to the next level with MIDI’s Quality Process.
MIDI’s Quality 1st Management Process:
At MIDI, our commitment to excellence begins with our QMS, DevelopmentDNA, and our quality process, Quality 1st, which follows the highest development standards from a project’s inception through certification, across all our teams. We possess the flexibility to adapt and work within our client’s quality management system or utilize MIDI’s ISO13485-ready and cloud-ready QMS which follows FDA work processes of Design Controls with traceability and Risk Management for medical device development. Our quality resources seamlessly integrate at any stage, whether it be pre-commercialization or post-commercialization, ensuring the utmost in professional guidance and support.
Our design and development activities, along with their corresponding outputs, are in strict compliance with the most recent medical device standards, including ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle Processes) and IEC 62366 (Usability Engineering). Capitalizing on our extensive experience within the medical device industry, we have built SOP’s (Standard Operating Procedures), work instructions and processes to ensure efficiency, effectiveness and superior quality. Our expert quality team and project managers are well-equipped to evaluate existing Design History Files (DHFs) for compliance with current standards and regulations, or to assist in the creation of a new DHF from the ground up.
Navigating Development Standards and Their Implications
For startups and businesses new to implementing and understanding standards, the process can be challenging. Our team is here to provide guidance and support, helping you become acquainted with the essential standards for medical product development, or simply to adopt best practices and comprehend the associated constraints. Our expertise ensures a smoother transition into compliance and the successful integration of these critical guidelines into your operations.
Strategic Planning for Standards-Compliant Activities
The Quality Assurance Team at MIDI offers expert support in the high-level planning and strategy development activities in compliance with medical standards. Through our comprehensive Quality Planning and Process, we ensure that our development approach adheres to the essential regulatory standards and requirements, allowing you to experience confidence with the integrity of your project’s progress.
Documentation
The quality assurance team offers the client a documentation framework to meet the high standards of medical product development.
Risk Management
Risk management plays a crucial role in medical product development. Our dedicated quality team diligently oversees the execution of risk analysis and management activities at every stage of the development process, ensuring that potential hazards are identified and mitigated to maintain the highest standards of safety and efficacy.
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