Aerospace & Defense
Innovation and collaborative, synchronized program management for new programs
Ensuring quality and regulatory compliance while also delivering best-in-class, innovative medical devices has never been more important. Our Operational Excellence solutions enforce regulatory compliant manufacturing operations while enhancing the ability to define, schedule, execute and assure manufacture processes that optimize quality and efficiency. Additionally, our product analytics solutions provide proactive quality insights and decision-making support based on manufacturing and quality big data.
Explore the key areas of this solution.
Create detailed med device production plans for production orders, optimizing use of your manufacturing assets.
Respond flexibly to production orders, creating production workflows from templates for medical device manufacturing execution.
Include inspection operations in production workflows for quality assurance in medical device development.
When inspection operations identify medical device and equipment non-conformances, enforce resulting workflows for rework, scrap and quarantining.
Enforce proper sequencing of medical device manufacturing operations and accurately record material consumption.
Create the required regulatory records for discrete-manufactured medical devices as well as formulated products.
Print labels on-demand using production identifiers that are specific to the medical device, batch or lot.
Leverage graphic and written work instructions and medical device specifications as part of the efficient and enforced production workflow.
Incorporate 5M and Lean principles in defining workflows and quality assurance operations for medical device and equipment manufacturing.
Measure, report, and control key quality and production metrics at your medical device organization.
Communicate with various systems and platforms for advanced automation and increased efficiency in medical device manufacturing.
Identify and manage non-conforming materials in your med device business according to an approved disposition management program.
Drive improved medical device performance back into design, engineering and manufacturing by combining and analyzing big data sources within a single, integrated platform.
The FDA and other regulators continue to emphasize mature quality assurance practices over baseline compliance activity. This heightened focus, referred to as the Case for Quality, along with globalization, economic factors, and a growing and competitive marketplace, are key factors driving Operational Excellence within the medical device industry. Similarly, greater device complexity and the increased occurrence of safety issues and recalls have heightened the need to enforce quality, efficiency and traceability in manufacturing operations.
Medical device organizations must produce devices using a digitalized manufacturing platform that provides production, supplier and purchasing controls. They must also take advantage of advanced big data product analytics to improve quality, reduce operational costs and mitigate risks.
Our proven Operational Excellence solutions deliver this critical functionality, enabling medical device organizations to excel.
Learn how our customers benefit from this solution.
Achieve Operational Excellence at your medical device company with our data-driven manufacturing solutions, ensuring quality and minimizing costs. Produce better devices while adhering to regulatory mandates for production controls and adapting to a complex, ever-changing marketplace.