Quality Management System
Quality management is a multidimensional requirement
CHALLANGE
Quality Management covers everything from verification that a finished product meets certain expectations, to manufacturing process, R&D, and post-market surveillance. As a component of regulatory standards, quality management requires a system for controlling, monitoring, and verifying any activity or process that could affect product conformance. Across the product life-cycle and throughout the entire organization, the importance of having full business alignment with a culture of quality has never been more important.
SOLUTION
QRT works collaboratively with clients to guide quality management strategies. Our team possesses the experience to devise customized solutions to develop a quality system that supports compliance and can build locally focused or company-wide strategies for meeting regulations within the medical device field.
QRT consulting services cover the full range of quality systems initiatives, including:
Internal process and quality system audits/assessments
Pre-certification audits
21 CFR 820 Regulations & compliance
MDR Regulation & compliance
ISO13485:2016 standard & compliance
Document control
Design control
Manufacturing and production processes
Standard Operating Procedure (SOP) development
Supplier quality and purchasing controls
Labeling consistency and accuracy
Complaints, Corrective Action/Preventive Action (CAPA), Adverse Event (AE), Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) processes and systems
QRT can also provide customized training based on an organization’s requirements, to ensure teams are utilizing the current best practices. We offer instruction on areas such as Good Manufacturing Practices (GMP), Quality System Regulations, ISO 13485 & 14971, Medical Device Regulation (MDR), auditing, validation, specific regulations, and related quality management topics. Whether sessions are delivered via classroom or remote classroom instruction or a learning management system, our training approach provides instruction that’s directly applicable to your business needs.
BENEFIT
Ensuring that medical devices, meet a high level of quality is a product lifecycle undertaking.
- The processes, testing, and documentation behind those products must follow a consistent process and meet current regulations.
- Each member of an organization, from executives to resource suppliers, plays a role in how quality is factored into a company’s operations
- QRT can help guide your company customize your quality system to deliver a repeatable and ongoing standard.