Medical device companies face many challenges in today's market, with the global economy, outsourcing, and product safety concerns. Maintaining and performing at a high level of standards produces safe, high-quality products with a reasonable return on investment. But how can you increase productivity while maintaining robust quality standards? These 6 manufacturing mantras can help you stay on track without skipping the essential checkpoints.
In Medical Design Technology's publication, Bart Reitter shares 6 Mantras for Medical Device Manufacturers. Based on these mantras, KMC Systems weighs in on how to achieve optimal, compliant results:
1. Global Compliance Challenges
Ensuring that they meet current good manufacturing practices (CGMP) as defined by the U.S. Food and Drug Administration (FDA), medical device manufacturers will benefit from technology suited for their needs. A one-size-fits-all approach in this industry does not work. That's why it's crucial to customize processes for your business and, most importantly, your customers' needs.
As an ISO 13485 certified and FDA registered company for over thirty years, KMC Systems is committed to regulatory and quality standards, product safety and global product certification for medical device contract manufacturing. Our robust quality assurance processes are continually improved as the global economy and regulatory requirements evolve.
2. Manual vs. Automated Processes
Transforming innovation is achieved with effective solutions and integrated quality functions, preserving capital, and complying with global regulations.
KMC Systems manufactures world-class medical devices and instrumentation by employing a customized, integrated manufacturing execution system (MES). Enabling rapid start-up, strong quality control, and documentation traceability for regulatory compliance. Our customized, FDA-compliant, automated medical manufacturing software was designed specifically for quality assurance in the design, development and manufacture of complex applications.
3. The Cost Versus Risk Conundrum
Medical device manufacturers are constantly balancing cost versus risk. Determining the optimum point where cost and risk intersect is a critical factor when strategically planning production.
When analyzing these risks, it's important to develop a strategy of assessment. KMC Systems' strict sourcing evaluation includes the completion of a thorough Supplier Survey. This is a critical step in successfully bringing innovative, ground-breaking and compliant biomedical products to market.
4. Integrating Quality Processes
The FDA requires medical device manufacturers to have a quality system in place. Having a deep expertise in medical manufacturing and engineering services, KMC focuses on reduced medical manufacturing costs and accelerated time to market - while never sacrificing quality. Our robust Quality Management System (QMS) ensures compliance with FDA Quality Systems Regulation 21 CFR Parts 820, 803 and 806 as well as ISO 13485. This customized system includes step-by-step visual instructions and our own quality assurance processes for consistently reliable quality and workmanship.
5. It’s All in the Cloud
Utilizing cloud technology allows medical manufacturers to achieve results rapidly by deploying a comprehensive system that focuses on innovation, meeting compliance goals, and preserving capital. KMC Systems works in close collaboration with customers, integrating customer and KMC teams of engineers and project managers - whether in one facility or in separate corners of the U.S.
6. The FDA’s Analysis
Managing risk through instilling quality standards and procedures assists in being more productive in the workplace, and successfully leverages compliance in regulatory findings.
KMC Systems has the competitive advantage in this proven process allowing for cost-effective, on-time delivery of innovative biomedical instrumentation that meet and exceed your medical product requirements.