Trends in 4.0 quality of the medical device manufacturing industry (Part 3)

Quality 4.0 is the convergence of new technologies that create new production contexts. In the medical device manufacturing market, in particular, there are many challenges to designing and manufacturing safer devices when businesses know how to approach and apply 4.0 quality in the right and effective way.

Medical device companies will gain a competitive edge by tapping into more product insights and quality management practices. This, in turn, will lead to better data-based decisions and multifunction visibility with quality, engineering, operations and supply chain teams. These 4.0 Quality conversion technologies will become increasingly complex in meeting the rigorous medical device requirements:

ISO quality system requirements

• Managing complaints and corrective action (corrective action) (CAPA)
• FDA 21 CFR Part 820
• FDA 21 CFR Part 11
• ISO 13485

To ensure compliance, a solution of the Quality Management System (QMS), product-centric, medical device manufacturing enterprises can:

• Create a fully connected quality and product process
• Establishing quality product processes to avoid audit issues
• Ensuring design can track and control changes
• Manage product invoices of materials that are directly linked to quality records

Promote closed-loop quality and corrective and preventive action (CAPA) procedures for faster resolution

Improve compliance quality and supplier management process

The last point in the supplier management process is essential because the appropriate QMS solution can unify the quality and product profile management to provide complete, traceable control and traceability. Chemical audit and risk reduction.

Practical application cases at equipment manufacturers

Swan Valley Medical is a manufacturer of surgical instruments and accessories for urological applications. They have been burdened with paper-based manual processes, not guaranteed efficiency, resulting in non-compliance with potential error control due to misplaced important documents. During an audit, when missing or incorrect information is found, it is difficult to recover and can take hundreds of hours or even months.

With the QMS solution focusing on cloud-based products, procedures to observe root causes and accelerate risk management have been implemented. This allows the connection of various processes through quality profiles and linked products, thus supporting effective auditing with a chain of evidence that is cross linked.

Productivity and Quality Office