DSI - DS InPharmatics, a PLG company’s Post

The monitoring and transparent traceability of products is more important in the #medicalsector than in any other industry. Read in our white paper “PIM in the healthcare industry”, how essential it is for medical device manufacturers to focus on optimal #dataquality right from the start: https://hubs.la/Q02r0W4J0

Explore the critical balance between healthcare innovation and safety in our recent article on the U.S. regulatory agency’s updated Q-Submission program. Learn how this program fosters dialogue between medical device manufacturers and regulators, paving the way for innovative and safe medical technologies. 👉 https://hubs.ly/Q028KCSD0 #medicaldevices #healthcareinnovation

Different countries = different approaches for healthcare reprocessing = different validations! How can you manage this? In our on-demand webinar, Katleen Peymen, Senior Expert Healthcare Reprocessing, will guide you in designing processing instructions and validations for reusable medical devices for the target markets EU and/or US. Watch the webinar: https://ow.ly/wQfG50ROFMJ #PatientSafety #IFU

Designing effective medical devices is a complex task that demands a thorough understanding of healthcare regulatory compliances, solution requirements, and the expectations of end-users. This blog featured in Health Tech World provides medtech experts with a complete guide to navigate the intricacies of medical device design, ensuring not only regulatory adherence but also delivering value to end-users in a highly competitive market. https://lnkd.in/eesz782m

On December 15, 2023, the Team-NB Position Paper relating to Medical Device Lifetime was published. This document examines every aspect of the Regulation, the standards and other guidance documents necessary to specify what the lifetime of a DM is and what is needed to demonstrate it. This document briefs and identifies all the different types of medical devices and how their lifetime should be demonstrated. The document is therefore a valid guide for manufacturers who must demonstrate and document the lifetime of their medical devices through clinical data. Source: https://lnkd.in/en3AWJBA #mdr #teamnb #positionpaper #mdlifetime #medicaldevices #regulatoryaffairs #qualityassurance #vlfconsulting

Pre-submission medical devices represent a pivotal step forward in the quest for better patient care and improved outcomes. These devices undergo rigorous evaluation and testing before submission to regulatory authorities, ensuring they meet the highest standards of safety, efficacy, and quality. Dive into the Future of Healthcare with Our Latest Article on Pre-Submission Medical Devices! Reach out to us to know more! #medicaldevices #FDA #healthtech

Different countries around the world have different healthcare practices, but also different regulatory expectations. In our on-demand webinar, Katleen Peymen, Senior Expert Healthcare Reprocessing, will guide you in designing processing instructions and validations for reusable medical devices for the target markets EU and/or US. Watch the webinar: https://ow.ly/wQfG50ROFMJ #PatientSafety #IFU

The medical device industry plays a crucial role in improving patient care, but did you know that medical device manufacturers face challenges that can have significant implications for patient safety, regulatory compliance, and overall business operations? Our article explores how manufacturers can overcome these challenges leveraging the powerful capabilities of Salesforce: https://bit.ly/4eMB61A #Argano #Manufacturing #MedicalDevice #HealthCare #PatientCare #Salesforce #SalesforcePartner

This week's blog delves into design validation as a critical step in the development process of medical devices highlighting the significance of ensuring safety, effectiveness, and compliance of the final product through testing and validation under realistic conditions. It also explores the key aspects of design validation, including its role in confirming device safety, performance, and regulatory compliance resulting in better outcomes for patients and healthcare providers. #designvalidation #medicaldevice #validation #compliance #regulatorycompliance #healthcareproviders #saltmedical #blog https://lnkd.in/eBaM_rFX

🌟 Navigating the Complex World of Medical Device Development 🌐 Our newest blog unravels the intricacies—from FDA classifications to breakthrough innovations. Discover the evolution of groundbreaking healthcare solutions and gain insights into the cost considerations shaping the industry. Dive into the details: 🏥 Understanding the FDA's vital role 🔬 Unveiling the Development Journey ✅ Decoding the FDA Approval Process 💡 Breakthrough Devices Program: A Game-Changer 💰 Cost Considerations: What's Behind the Numbers? Link in the comments! 🔗 Don't miss this comprehensive guide to the heartbeat of medical innovation. Knowledge is power! 💪 #MedicalDevices #FDAApproval #HealthcareInnovation #MedicalTechnology #IndustryInsights