How Strong Design Controls Simplify Compliance and Eliminate Audit Anxiety
Achieving regulatory compliance is a hurdle for medical device manufacturers. Missteps and inefficiencies addressing FDA, ISO, and other regulatory directives can result in delays, warning letters, and even business closure. Design controls are at the heart of the FDA’s quality system regulation specified under Title 21 CFR Part 820. For medical device companies, adhering to quality standards throughout the new product development and introduction (NPDI) process requires strong design controls.
7 Principles of Product-Centric Quality Management
Having a rock-solid approach to quality is a prerequisite for medical device success. The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards, market requirements, and device complexities have evolved, so too has the weight of the burdens these leaders face. Read how product-centric QMS enables complete control and increased transparency throughout the new product development and introduction process.
Product Centric QMS: A Critical Advantage for Regulated Companies
Medical device manufacturers must establish quality systems to comply with FDA regulations and other standards like ISO 13485. A single, unified quality management system (QMS) to manage documents, SOPs, training records, and quality processes in context with the entire product record increases visibility and traceability between all impacted teams. Read how product-centric QMS speeds product launches and reduces compliance risks.
Don't Fear the Cloud - Debunking the Top Three Myths Regarding Multi-Tenant Cloud-Based PLM Architecture for Medical Device Firms
Download this whitepaper today and learn the facts behind the misconceptions that are causing trepidation among medical device firms, when considering cloud-based PLM systems. Read more and discover how cloud-based enterprise software can: Ensure leading-edge data security over traditional off-the-shelf enterprise software and add-on components Easily and cost-effectively achieve up-to-date validation; with minimal time and effort Assist with reducing expensive non-conformances, attaining better communication and ultimately increasing product quality. ...and more.
How Med Device OEMs Simplify Validation & Streamline Compliance
The complexity of validating updates to software has forced many cutting-edge medical device companies to forgo updates, upgrades, and bug fixes. Unfortunately, running outdated software curtails their success. The good news is that medical device companies can have the latest, best versions of their enterprise software with minimal validation effort and cost. In this whitepaper, you'll learn: Powerful benefits of a cloud-based Software Validation Maintenance Service Key regulations impacting medical device manufacturers FDA’s general principles of software validation For medical device companies ready to learn more about the powerful benefits of a cloud-based PLM validation service, download this whitepaper today.
Avoid the High Cost of Quality Failure
This whitepaper highlights the best practices and benefits of managing quality. Results discussed include improved time to market, higher product quality, reduced costs with higher margins, and an increase in innovations.Solutions discussed within the white paper address these issues:80% of quality issues are repeat issues for which a corrective action has already been identified but does not persist.PLM and QMS interoperability can help reduce internal & external failure costs by more than 50%Increase operating margin 25%The ability to proactively monitor errors and product failures with enterprise-wide visibility is only possible with a holistic approach to quality. Unfortunately, only few companies have achieved this deeply embedded 'best practices' level of standards.Read the whitepaper here.
Best Practices for Medical Device Manufacturers to Ensure Quality
This free white paper will focus on using appropriate software applications that can enhance visibility, data access, analysis, and process improvement. It is well known in the medical device industry that the success of a company is driven by its ability to bring innovative, cost-effective products to market quickly. And, in today’s global medical device market, proactive strategies are needed to ensure compliance with the regulatory requirements in global markets. As the Food and Drug Administration (FDA) and other regulatory bodies have embraced the concept of total product life cycle (TPLC) management, it has become the gold standard for guiding a medical device from concept to completion. In this white paper, you'll discover:How to improve product quality, reduce cost, and increase businessBenefits of Product Lifecycle Management (PLM)How to implement a PLM solution to address TPLC management
Reduce Regulatory Delays by Formalizing Design Control Processes
The medical device industry stands at the crossroads between innovation and increased regulation. The lack of formal Design History Files (DHF) and Device Master Records (DMR) are one of the most important reasons for issuing non-conformance directives to medical device makers requesting regulatory approval for new product introductions. Luckily, effective Product Lifecycle Management (PLM) solutions, such as Arena BOMControl, can help to facilitate proper management of quality documentation in order to ease the pains of the regulatory approval process while accelerating time to market.In this whitepaper, we outline how Arena PLM can help medical device companies achieve the following:· Improve design collaboration among global supply chain teams· Formalize design and document controls procedures and product record management.· Streamline compliance and auditsDiscover how a validated patented cloud PLM solution, document management capabilities expedite faster compliance approval by formalizing Design History Files (DHF) and Device Master Records (DMR) design processes to streamline and accelerate regulatory approval processes.
Warning: Everything You Know About Medical Design Is Wrong
According to an Aberdeen Group report, embedding quality and design control processes within a PLM solution can reduce internal and external failure costs by more than 50% and reduce the total cost of quality by 8%.But an alarming number of med devs go bankrupt due to a bad advise that supports investments in disparate design processes systems. Unfortunately, NPI delays, scrap, rework and an increase in costly risk make these manufacturing execs realize too late that everything they were told about design control was "wrong".This medical device whitepaper proves when quality is embedded in the product design and development cycle - coupled with modern risk management tools - supply chain oversights, employee missteps and product design errors can be dramatically reduced. In this whitepaper, you'll discover:How to increase operating margin 25%How to reduce failure costs 29% with integrated PLM and quality toolThe best next generation design solutions for medical devicesIntegration strategies for reducing obsolescence and counterfeit part risks
Has Your BOM Solution Bombed?
Arena SolutionsIn the world of product design and manufacturing, the bill of materials (BOMs) is a critical product information record for both the engineering and manufacturing teams. Managing BOMs with the wrong tools can cause product errors, delays and compliance failures.In this whitepaper, we outline the problems with manual BOM management tools like spreadsheets and email and compare them to a dedicated BOM management system.
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