Meeting medical device regulations with quality process efficiency

Complexity is a growing part of the medical device industry. As healthcare providers expect products that are increasingly powerful, tailored and connected, that complexity is adding unsurmountable challenges for medical device manufacturers in meeting market demands. On top of that, health authorities are changing regulatory requirements and adopting stricter medical device regulations.

Also, the extent of damage that limited cooperation between engineering, quality and manufacturing teams can cause ripples throughout the manufacturing process and impact medical device compliance. This lack of collaboration can create the potential for miscommunication and late identification of design and quality issues, which can lead to substantial time and effort spent for revising work.

The risk of a product recall is always an underlying concern in medical device manufacturing and can impact patient safety and erode trust in the company. In medical device manufacturing, the inability to identify potential problems, such as design errors, are a significant cause of quality issues and present a looming possibility of product recalls. How are medical device manufacturers balancing delivering high-quality and innovative products faster with tightening margins, all the while remaining competitive?

Streamline design and development

Meeting the demands of healthcare providers and patients, competing in an ever-evolving environment and succeeding amid the complex web of medical device regulations requires a comprehensive digital transformation approach.

At Siemens, we offer a closed-loop quality management solution that:

• Streamlines design and development
• Ensures efficiency and compliance
• Enhances product quality from start to finish
• Fosters a comprehensive quality approach
• Enables users to perform functions in all stages
• Reduces costs throughout the entire product lifecycle by optimizing design, production and pre- and post-market approval steps and processes

Process efficiency with a comprehensive Quality Management System

With a quality-by-design and closed-loop management approach, your engineering teams can be involved early in the process and create greater opportunities for your products to reach the market quickly, cost-effectively and maintaining patient safety.

Quality process efficiency enabled by Siemens Closed Loop Quality and Compliance tools minimizes risk. With a comprehensive Quality Management System (QMS), medical device manufacturers can provide full traceability starting from design development going all the way through to post-market surveillance. A management system approach like this is designed to enhance quality processes through each manufacturing execution step.

Quality through a fully integrated management system

What would it mean if you could systematically investigate, analyze and resolve quality concerns early in the process? Quality process efficiency tools, part of Siemens Closed Loop Quality and Compliance, offer an enterprise-wide solution for ensuring medical device compliance.

With an integrated management system, you can expect all relevant project and product information and documents to be centrally planned, monitored and managed as well as product and quality planning support for all phases of the product development process

This includes:

• Quality process planning and definition
• Product and process design and development
• Product and process validation
• Feedback and corrective action

Manage quality processes in the cloud with Teamcenter X Quality

With Siemens Teamcenter X Quality, you can embed quality and compliance processes across the product lifecycle and turn complexity into a competitive advantage. Our cloud solution helps you get started with preconfigured, built-in quality best practices so you can experience its immediate value. Automatic product improvement updates include the newest quality process enhancements, and the user-friendly interface makes it easy to manage quality and compliance processes.

Teamcenter X Quality helps you mitigate the risk of noncompliance which leads to higher customer satisfaction and better protection of you brand reputation.

Address quality with a comprehensive management system for medical devices

Medical device compliance and quality go hand-in-hand. With the software solutions to support digital transformation across the entire product lifecycle, you’ll have the tools to implement end-to-end quality.

Siemens can help medical device manufacturers:

• Manage quality issues from internal sources, suppliers and customers
• Carry over relevant issue information by identifying and solving process problems
• Execute defined inspections seamlessly on the shop floor

Medical device manufacturers must take a holistic approach to quality and dedicate their processes to supporting the production of quality products – from design to manufacturing and back – and meeting the standards in place by medical device regulations.

Quality process efficiency, as part of the Closed Loop Quality and Compliance solutions by Siemens, will contribute to mitigating patient risk, anticipating corrective actions and optimizing effort and capital costs related to quality issues.

Quality control is therefore covered ensuring continuous improvement in the product quality, audits, compliance, test and qualification.

Read our ebook to learn more about quality process efficiency.

Ready to take our quality management solution for a test drive? Try our 30-day free demo today!