Eisner Safety Consultants’ Post

Ensuring IEC 60601-1 compliance can be a complex and daunting task.   The challenge? Integrating this with other standards like ISO 13485, ISO 14971, and IEC 62366. → Grasp the core requirements of each standard. IEC 60601-1 focuses on electrical safety. ISO 13485 is for quality management. ISO 14971 addresses risk management. IEC 62366 covers usability. → Each standard has unique requirements, but they often intersect. Identify these overlaps early in the development process. → Develop a comprehensive plan that addresses all relevant standards. Avoid redundancy and ensure all requirements are met efficiently. → Involve teams from different departments. Quality, engineering, regulatory, and usability experts should work together. Cover all aspects of compliance. → Maintain detailed records of your compliance efforts. Proper documentation can simplify audits and inspections. → Keep your team updated on regulatory changes. Regular training sessions can help them stay current and proficient in compliance requirements. → Conduct internal audits to identify gaps. Regular reviews help in keeping the compliance process on track. → Engage with regulatory experts. They can provide insights and help navigate complex regulatory landscapes. Follow for daily insights into tech product development. #MedicalDevices #Quality #Regulatory #Safety #SimplifyingInnovation #Unplex

Get ready! At 10-10:45am CET, our Head of Safety Management Philipp Hofmann will be hosting a webinar on the importance of establishing a safety culture in companies. You can still register for the event by checking out our website (link in comments). The event is free to attend and will be conducted in German. In our webinar, we will cover the current challenges and safety constraints in product development, the benefits of an established safety culture, and the various consequences of including safety at different project stages. You also get the chance to learn about IFSA, our functional safety assessment for ISO 26262, IEC 61508, and DIN EN 50126, and how it can help you prepare for your upcoming safety audits. #technology #innovation #productdevelopment #safetymanagement #safetyculture

ISO 17025, requirement 7.1 states that your laboratory must have a procedure for the review of requests, tenders, and contracts. This procedure must ensure that: The requirements are defined, documented and comprehended. The lab has the capability and resources to meet the requirements. Download 20+ SOPs: https://lnkd.in/gcBTNYsV #measurement #measurements #calibration #recalibration #calibrations #testing #manualtesting #uncertainty #embraceuncertainty #uncertaintyprinciple #iso17025 #isoiec17025

🚀 Breaking Down ISO 17025: What You Need to Know for Lab Testing 🧬🧪 Hello LinkedIn Community! As a dedicated professional in the testing services industry, I've seen firsthand how the integrity and reliability of laboratory results hinge on stringent standards and best practices. Today, I want to shed light on one of the key standards that we, as testing service providers, live by: ISO 17025. 📜 What is ISO 17025? ISO 17025 is the globally recognized standard for testing and calibration laboratories. It addresses both technical and management requirements, ensuring that laboratories consistently produce valid, reliable results. Here’s a brief breakdown of its core components: 🔍 Key Elements of ISO 17025: 1. Scope: Applies to all organizations performing laboratory activities, regardless of the industry. 2. Management Requirements: Focuses on lab policies, systems, and documentation for ensuring quality and continuous improvement. 3. Technical Requirements: Encompasses laboratory competence, covering staffing, methodology, equipment, and quality control. 💼 Why It Matters: - Credibility: Lab accreditation under ISO 17025 signifies a trustworthy and competent service. - Consistency: Ensures uniformity in testing methodologies and results. - International Recognition: Facilitates greater acceptance of test results across borders, boosting global trade and cooperation. 🌟 Our Commitment to Excellence: At KineAnalytix Services Sdn Bhd, we prioritize achieving and maintaining ISO 17025 accreditation because it represents our commitment to precision, accuracy, and excellence in testing. This standard not only assures our clients of the reliability of our results but also reflects our dedication to continual improvement and upholding the highest industry standards. 📈 Impact on Our Clients: - Enhanced Confidence: Clients can trust the accuracy and reliability of test results. - Compliance: Helps in meeting regulatory and industry requirements effortlessly. - Risk Mitigation: Reduces errors and discrepancies, ensuring safer and more effective outcomes. For businesses relying on laboratory testing, understanding and embracing ISO 17025 can offer profound benefits. As we continue to navigate an increasingly complex regulatory landscape, adhering to this standard is not just about compliance—it’s about building a foundation of trust and quality. 💬 Let's Connect and Discuss! Feel free to reach out if you want to know more about how ISO 17025 can enhance your lab operations or if you're looking for a partner who holds these standards in high regard. Let's advance together in ensuring meticulous, reliable testing for the betterment of all industries. #ISO17025 #LaboratoryTesting #QualityAssurance #TestingServices #LabAccreditation #IndustryStandards #ContinuousImprovement

🔍 Navigating IEC 60601-1 Labelling Requirements Simplified! 🔍 Are you finding it challenging to keep up with the scattered labelling requirements in IEC 60601-1? Have you occasionally overlooked some markings or disclosures in the Instructions for Use? You're not alone! The IEC working group recognized this issue and offers a solution. Did you know about Annex C? This informative section, “Guide to marking and labelling requirements for ME EQUIPMENT and ME SYSTEMS,” consolidates all the scattered requirements into comprehensive overview tables. Each table addresses specific topics such as marking on the outside, technical description, and more. Next time you need to ensure your labelling is complete per IEC 60601-1, make Annex C your go-to reference and checklist. Need support with IEC 60601-1 compliance? Contact me or leave a comment below, and I'll get back to you as soon as possible! #IEC60601 #MedicalDevices #Compliance #Labelling #QualityManagement #RegulatoryAffairs

Learn about the importance of the ISO 9001 standard and some essential procedures and considerations to make when using the standard. https://bit.ly/48yHghg

step-by-step procedure for controlling design and development changes according to ISO 13485:2016: under sub clause 7.3.9 Control of design and development changes 1.Identification of Need for Change: Identify the need for a design change, whether it's due to customer feedback, regulatory requirements, or internal improvements. 2.Documentation of Change Request: Document the details of the proposed change, including the reason for the change, potential impact on product quality, and any regulatory implications. 3.Review of Change Request: Review the change request by a designated team, which may include representatives from design, quality assurance, regulatory affairs, and other relevant departments. 4.Impact Assessment: Assess the impact of the proposed change on product safety, performance, and regulatory compliance. Determine whether additional testing or validation is necessary. 5.Approval: Obtain approval for the change from appropriate stakeholders, such as management, regulatory authorities, and customers, as applicable. 5.Documentation Update: Update relevant documentation, including design documents, risk management files, and regulatory submissions, to reflect the approved change. 6.Implementation of Change: Implement the approved change in accordance with established procedures, ensuring that all necessary resources are allocated and that any associated risks are mitigated. 7.Verification and Validation: Verify and validate the effectiveness of the change through testing, inspection, and other appropriate methods to ensure that product quality and safety are maintained. 8.Training: Provide training to personnel affected by the change to ensure they understand their roles and responsibilities in implementing and sustaining the change. 9.Communication to stakeholders: Communicate the change to relevant stakeholders, including employees, suppliers, and customers, as appropriate, to ensure awareness and facilitate a smooth transition. #controle of design and development changes #function #performance #usability #safety#Regulatory requirements #reviewed #verified #validated as appropriate #approved #iso 13485:2016

Equipment and instruments must be calibrated to ensure proper operation, and the ISO 17025 accreditation is critical to elevating standards in the calibration business. Read more: https://lnkd.in/g5A4F6U7 #YourPartnerinCalibration #QualityBeginsHere

Making ISO9001 Easy for Engineers: Clause 5.2 – Policy For any organization to function effectively, there must be a clearly defined and agreed-upon policy. The scope and extend of documented policy is shaped by statutory, regulatory, and organizational requirements. When it comes to the Quality Policy, it’s crucial to ensure that the policy is aligned with the purpose, context, and strategic direction of the organization. This is why top management must take responsibility for establishing policy, communicating policy and reviewing policy. The Quality Policy should also set a framework for company objectives, reinforcing that accountability lies with top management. Keep the policy clear and concise. It’s important not to confuse the policy with the procedure. Think of the policy as a compass that defines where the organization is headed, while the procedure is the roadmap detailing how the organisation will get there. These are two distinct documents, often created at different levels within the organisation, reviewed at different intervals, and shared with separate internal and external audiences. Once your policy is finalized, ensure all staff are aware and acknowledge its importance. Additionally, make the policy available to external stakeholders when appropriate. It can be a powerful marketing tool, so consider showcasing it on your website, in email signatures, or other communication platforms. Best of luck in developing your organization’s policy and fostering a strong culture of quality within your organisation! Should you have any questions, feel free to contact me at diane.liebenberg@dcx7.co.za. Also, don’t forget to check out previous posts for insights into other ISO9001 clauses. #quality #engineering #ISO9001 Disclaimer – this post reflects the opinion of the author based on past experience using ISO9001 within the engineering industry and should not be taken as professional advice.  

Staying certified after the Deadline, 26th May 2024 - EUMDR - CE certification, #EUMDR #26thmay2024deadline #Staycerified #evenafterdeadline What? The MDR took your CE Certificate Away?" The final deadline of May 26, 2024, is approaching fast, and manufacturers must understand that not complying with Article 120 3c of the MDR means automatic invalidation of device certificates. This isn't a decision by a Notified Body; it's mandated by the MDR itself. Here is the checklist for staying certified even after 26th May 2024 1 Directive Compliance: Devices must continue to comply with Directive 90/385/EEC or 93/42/EEC. A. Design Stability: No significant changes should be made to the device’s design and purpose. B. Risk Management: Devices must not pose unacceptable health or safety risks. C. Quality Systems: Implement a quality management system as required by Article 10(9) before May 26, 2024. D.Notified Body Application: Submit a formal assessment application to a notified body by May 26, 2024, and ensure the contract is signed by September 26, 2024. From my discussions with manufacturers, it's clear that not everyone fully understands these requirements. Now is the time to double-check that every requirement is met. Missing even one can mean your product is pulled from the market. There’s no flexibility with the MDR when it comes to these requirements. As the deadline approaches, make sure your products comply fully to avoid losing your certification. Best Dr Vidya