Streamlined Medical Device Regulatory Compliance with Arena Solutions PLM

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Streamlined Medical Device Regulatory Compliance with Arena Solutions PLM

Simplify FDA, EU MDR, and ISO Compliance

Medical device manufacturers are tasked with ensuring patient safety by meeting stringent regulatory compliance requirements from organizations like the FDA, EU MDR, and ISO. Achieving and maintaining compliance with regulations such as FDA's 21 CFR part 820 and ISO 13485 is crucial for the success of commercializing medical devices. Arena Solutions PLM offers a cloud-based Quality Management System (QMS) software that facilitates the establishment of strong design controls, simplifying the management of standard operating procedures (SOPs), device history files (DHF), device master records (DMR), training records, and the overall product record. By linking all quality and product information throughout the new product development process, Arena's QMS software helps manufacturers streamline compliance.

Connected Quality Processes

In a regulated environment, connecting product and quality records is essential for introducing new medical devices while maintaining compliance. Arena's cloud QMS software takes a product-centric approach by linking quality, training, supplier, and audit records to the entire bill of materials (BOM). This connectivity optimizes closed-loop quality processes, reduces internal and external audit risks, and simplifies software system validation. By following the seven principles of product-centric quality management, medical device manufacturers can enhance regulatory compliance efforts and improve overall quality control.

Face Audits with Confidence

Arena Solutions PLM empowers medical device manufacturers dealing with Class I, II, and III devices to meet the requirements of FDA 21 CFR Part 820, Part 11, and ISO 13485. By centralizing control over design master records (DMR), device history files (DHF), SOPs, and training records, manufacturers can confidently face internal and FDA audits. The system offers support and tools to help manufacturers quickly find and retrieve necessary records, ensuring compliance with inspection requirements and facilitating a smoother audit process. Customers like Michelle J. Potvin from Swan Valley Medical have praised Arena for its effective support and functional solutions that aid in compliance and quality assurance efforts.

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Accelerating Product Launches with Arena Solutions PLM and QMS

Streamlining Product Development

Arena Solutions PLM and QMS are cloud-native solutions designed to keep product teams and partners aligned, ultimately speeding up product launches. These innovative platforms empower customers to enhance process efficiency, drive growth, and expedite product development. By leveraging Arena PLM and QMS, organizations can realize significant benefits, such as delivering high-quality products ahead of schedule and within budget. The unified platform streamlines product development processes while ensuring regulatory compliance, providing anytime, anywhere access to critical PLM and QMS information.

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Streamlining Product Development with Arena Solutions PLM

Innovative Cloud Solutions for Modern Manufacturing

Arena Solutions PLM offers cloud PLM and QMS solutions that are specifically crafted to assist modern manufacturing companies in streamlining their product development processes and commercialization while ensuring compliance with regulations. The cloud-native platform provided by Arena accelerates digital transformation by creating a unified source of truth that connects individuals, products, and processes.

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Enhancing Medical Device Design Controls with Arena Solutions PLM

Introduction to Design Controls in Medical Device Development

In the realm of medical device development, adherence to regulatory requirements, such as those set forth by the FDA, EMA, and ISO, is critical. Ensuring the safety and efficacy of these devices necessitates meticulous oversight of the design process, encompassing review, verification, and validation processes. Arena Solutions PLM offers a comprehensive solution that simplifies design control management, enabling teams to establish and track essential elements including user needs, design inputs, processes, outputs, and documentation.

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Arena Solutions PLM: Driving Success with Comprehensive Resources

Resource Library: Educational Insights for Product Teams

The Arena Solutions resource library is a treasure trove of articles, white papers, guides, tips, tools, templates, and ebooks focusing on product lifecycle and quality management. This rich repository offers valuable educational and best practice insights tailored for product design, quality, manufacturing, and supply chain teams. By accessing these resources, organizations can enhance their knowledge base and drive success in their respective industries.

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Empowering Your Product and Quality Processes with Arena Solutions PLM Best Practices

Streamlining New Product Development (NPD)

New Product Development (NPD) is a critical phase in bringing innovative products to market efficiently. With Arena Solutions PLM Best Practices, teams can learn how to streamline NPD processes across different departments. By centralizing data and communication, teams can collaborate effectively, leading to faster time-to-market and better product quality.

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