Are you a Risk Management expert? We are looking for a Senior Quality Engineer in Cypress, CA to assist in the development, maintenance, and continuous improvement of the global medical device risk management strategies and procedures for iRhythm products and processes. Think you're a good fit? Apply today! https://bit.ly/3YiXJ7P #JoiniRhythm
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How to integrate #RiskManagement in Design and Development of medical devices (post below); Get FREE trial of BPAMedical365® https://lnkd.in/exXS2PXk - From document control, to audit, non-conformances, risk and training management, BPAMedical365® is your all-in-one #Quality and #Compliance management platform, https://lnkd.in/exXS2PXk Achieving and maintaining certifications such as EU #MDR, #FDA, and #ISO13485 is vital for ensuring product quality, patient safety, and market access in #medical device-related industries, #healthcare, #pharma and life science sectors. Agile, scalable and #costeffective, BPAMedical365® https://lnkd.in/exXS2PXk is an all-in-one #eQMS software for medical quality and compliance management, ready to use in your trusted Microsoft 365 environment. Offering streamlined approaches and #automation across platform and devices, this #intuitive software is key to facilitate medical compliance and improve your teams’ #performance, https://lnkd.in/exXS2PXk #medicaldevices #BPAMedical365 #medtech #regulatoryaffairs #researchdevelopment #designdevelopment #designthinking
Take control of medical device compliance | Templates & guides | Practical solutions for immediate implementation
Risk management is king. 👑 If there is one process that must interact with all others, it's risk management. Let's focus on 4 concepts of risk management to integrate into your D&D process: ➡ The design and development of medical devices involve an evolutionary process focused on identifying and controlling risks, with the aim of reducing risk to an acceptable level while maintaining device functionality and feasibility. ➡ Risk management should start early in the design and development phase, emphasizing prevention over later correction, and involves estimating and evaluating risks in both normal and fault conditions to determine necessary risk reduction measures. ➡ The design process includes a cycle of input, output, and verification to continuously iterate and manage residual risks, ensuring they are reduced to an acceptable level and maintained there through effective risk control measures evaluated during design validation. ➡ Post-market risk management activities for medical devices should integrate with quality management processes like production controls and customer feedback, and all design activities aimed at controlling risks should be well-documented to demonstrate their appropriateness in relation to the degree of risk. Any other considerations to add? #eumdr #risk #riskmanagement #ISO #design #development #concept #medicaldevices #medicaldevice #medtech
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As a Medical Device Manufacturer, remember, in every single stage of Medical Device Life-Cycle, Risk has to be evaluated. Risk Management is not a single event activity, it is a continuous process. As what Business Risk is covered in Business Continuity Plan (BCP) and ISO 9001:2015, Medical Device Risk to be covered part of the Quality Management System of Medical Device. Not only Change Control and CAPA, but Purchasing Process, Sampling Plan, Design Development, Validation (including Software Validation), Calibration, Maintenance, Training Need Analysis with Training Evaluation, Supplier Evaluation & Selection, and even Internal Audit can be risk based approach. Risk Management not only assist industry to manage the process by risk priority, but also indirectly assist business to be managed efficiently. 💪
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Sr. Manager || QA || QC || QMS || CSV || DI || Compliance || IT QA || Training || Practicing Growth Mindset || Personal Development ||
While reading WHO Guidance on Quality Risk Management, terms "Inspection" and "Audit" we're separately quoted. Eager to know how #AI differentiates the two terms, asked the difference and here is the answer. Inspection and audit are both quality control processes, but they serve different purposes and have distinct approaches: Inspection: An inspection is a systematic examination of a product, process, or system to determine whether it meets specified requirements, standards, or regulations. Inspections typically focus on: - Verifying compliance - Identifying defects or deviations - Ensuring quality and safety Inspections are often performed during production, installation, or maintenance, and are usually conducted by a neutral third-party or internal quality control teams. Audit: An audit is a systematic evaluation of a process, system, or organization to determine whether it meets specified requirements, standards, or regulations. Audits focus on: - Evaluating effectiveness - Assessing compliance - Identifying opportunities for improvement Audits are often performed to verify conformity to standards, regulations, or internal policies, and are usually conducted by external or internal auditors. Key differences: - Purpose: Inspections focus on product or process verification, while audits focus on evaluating overall effectiveness and compliance. - Scope: Inspections are typically narrower in scope, focusing on specific products or processes, while audits are broader, examining entire systems or organization. - Approach: Inspections often involve a more detailed, hands-on examination, while audits typically involve a more high-level evaluation. Would like to know your opinion Paul Smith Ravi Chinchalkar Yan Kugel and all experts. #inspection #audit #pharmaceuticals
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Wondering how to achieve seamless compliance and efficiency in your processes? 🧐 eConsulting specializes in comprehensive technical validation services that encompass meticulous validation of processes, laboratory installations, utilities, cleanrooms, and a spectrum of equipment. Furthermore, we provide ongoing maintenance services to sustain the validated state of your equipment and installations. Our team conducts periodic reviews, requalification, and calibration to ensure continuous compliance and maximize performance efficiency. 🔴 We can elevate your business environment from a stage of non-compliance or compliance risk to a fully validated, audit-ready state. Reach out to us today to discover how our technical validation services can help you achieve smooth functioning and regulatory compliance in your operations. 👉 https://lnkd.in/dr2Wjx5h.. #Compliance #QualityAssurance #Validation #Regulations #Qualification
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ISO 14971 Risk Management for Medical Devices Learn about ISO 14971, a standard for managing risks associated with medical devices. Understand the process, terminology, and principles involved. Ensure compliance and enhance safety. Read more: https://lnkd.in/dhVq5wUf #RiskManagement #ISO14971 #Healthcare #SafetyStandards #MedTech #Compliance #MedicalDevices #QualityAssurance #HealthTech
Comprehensive Medical Device Risk Management ISO 14971 Guide
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Medical Laboratory Technologist & Microbiologist | Health and Medical Content Specialist | Bridging the Gap Between Complex Medical Science and Public Awareness | Advocating for Improved Healthcare in Pakistan |
🔍 The Backbone of Excellence: Quality Assurance 🔍 In today's competitive landscape, ensuring top-notch quality is not just a necessity—it's a game-changer. Quality Assurance (QA) plays a pivotal role in delivering accurate and reliable results in the lab. But QA is more than just a process; it’s a mindset. Here’s why investing in robust QA practices is crucial: - Building Trust: Consistent quality builds patients trust and loyalty, driving repeat business and positive word-of-mouth. - Cost Efficiency: Identifying and resolving issues early in the development process saves significant costs associated with post-release fixes. - Continuous Improvement: QA fosters a culture of continuous improvement, encouraging teams to innovate and enhance processes. - Compliance and Risk Management: Adhering to laboratory standards and regulations mitigates risks and ensures compliance, protecting both the lab/hospitals and its patients. Let’s embrace QA not as a checkpoint but as an ongoing commitment to excellence. After all, quality isn’t just an act; it’s a habit. #MLS #mlt #QualityAssurance #Excellence
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Laboratories carry a profound responsibility to deliver precise outcomes that uphold professional standards and meet customer expectations. Join our Statistical Method Validation Classes to equip your team with the essential tools and techniques for ensuring accuracy and reliability in analytical processes. Discover how method validation serves as a cornerstone for comprehensive quality assurance, essential for compliance with international regulations across diverse analytical fields. Don't compromise on precision – invest in the knowledge and skills necessary to safeguard your lab's integrity and ensure seamless business continuity. Register today to elevate your analytical capabilities! . . . . . #StatisticalMethodValidation #QualityAssurance #LabAccuracy #Compliance #BusinessContinuity
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#RiskManagement is not an isolated activity from design and development. It's not a separate task; rather, it's a vital aspect that enhances the overall process. When done effectively, it offers significant advantages by ensuring that potential risks are acknowledged and addressed throughout the device's lifecycle. Proper risk management facilitates the reduction of systematic errors within the design control process. It establishes a structured approach for evaluating design safety, leading to continuous enhancements. The key lies in seamlessly integrating risk management methodologies into the design and development phases. This integration ensures that: ◾ Risk management is ingrained in the natural flow of design and development. ◾ It adapts and evolves along with the device's design. ◾ #DesignControls are proportionate to the associated risks. ◾ Connections between hazards, requirements, and verification and validation testing are clear and traceable. ◾ Risk management processes serve as the basis for determining device safety and effectiveness. ◾ Risk assessments, reductions, controls, and monitoring measures are incorporated into the design output to maintain risk management throughout the device's lifespan. Remember, prioritizing risk management is essential for guiding all activities effectively. ➡ Explore our carousel to discover when and how to integrate risk management into each stage of your process. #MedicalDevices #ISO13485 --- Content inspired by EU MDR Compliance and MD+DI
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Quality Assurance in 200 Words or Less Findings Versus Comments The principal work product of auditors is Findings. Findings document specific instances of non-compliance with the regulations, contract, study protocol, or procedures. Findings are important because, cumulatively they give the sponsor a gauge as to how well the work is being performed. Findings give the laboratory an important outside perspective on how well they are doing in their day-to-day compliance. But not always. Auditors are often confronted by a situation that sets the stage for the possibility of non-compliance, but not actual non-compliance. If the sponsor allows the auditor to make Comments, the auditor can go “on the record” by voicing their concern. The Comment also serves as a marker for follow up during future audits. If the sponsor does not allow the auditor to make Comments, the issue sometimes ends up as a Finding. A poor Finding – one which is easily sidestepped by the lab in their response, and typically doesn’t achieve its intended purpose. Auditors hate being put into this position. Labs hate receiving these types of Findings. Sponsors are frustrated by the response they receive back from the lab for these Findings. Good labs appreciate Comments and good sponsors give this tool to the auditor.
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As a QA engineer, one of our key responsibilities is to evaluate suppliers to ensure that they meet our quality standards. This process is a critical in maintaining the quality of our products and services. Quality Management System: Does the supplier have a robust quality management system in place? Product Quality: Are the supplier's products consistently meeting our quality standards? Delivery Time: Is the supplier able to deliver products on time? Communication: Does the supplier communicate effectively and promptly? Compliance with Regulations: Does the supplier comply with relevant regulations and standards? Financial Stability: Is the supplier financially stable? Price Competitiveness: Is the supplier's pricing competitive? Reputation: What is the supplier's reputation in the industry? Customer Service: How does the supplier handle customer service issues? Capacity: Does the supplier have the capacity to meet our needs? Innovation: Is the supplier innovative and open to new ideas? Risk Management: Does the supplier have a risk management plan in place? By carefully evaluating suppliers based on these criteria, we can ensure that we are working with reliable partners who can help us maintain and improve our product quality. #SupplierEvaluation #QAEngineering #QualityManagement.
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