Schlafender Hase’s Post

We are thrilled to announce the release of our latest eBook: 𝗕𝗲𝘀𝘁 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲𝘀 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗟𝗮𝗯𝗲𝗹 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲 Navigating the complexities of medical device labeling can be daunting. Our comprehensive guide offers practical insights into: 🔍 Understanding #FDA and #MDR regulations ✏️ Designing clear, user-friendly labels ✅ Validating label accuracy and compliance ⚠️ Managing labeling risks to ensure patient safety This eBook is your go-to resource for mastering label management and enhancing both operational efficiency and product integrity. Download your copy today and take the first step toward streamlined compliance! #MedicalDevices #LabelManagement #RegulatoryCompliance #SchlafenderHase #eBook

In this article, I outline 7 mistakes often made by medical device companies with their corrective and preventive action process. For a free eBook on Why a Good CAPA Procedure is Required for an Effective Medical Device QMS as well as a selection of other eBooks go to this link: https://lnkd.in/gx5cywTn Also available are ISO 13485:2016 QMS document templates, including for Corrective and Preventive Actions (CAPA). https://lnkd.in/gYXi8Xn6 If you are looking for help with your QMSR transition our 41-page QMSR Gap Analysis Checklist is available for download: https://lnkd.in/gSbjhEnN. #iso13485 #fdaqmsr #qualitymanagement #qualityprocedures #capaprocedure #correctivepreventiveaction

So proud of my colleagues Patterson (Pat) Shafer and Cheryl Tan who helped author Drug Information Association's new eBook on regulatory information management (RIM). If you’re curious about expert strategies for improving regulatory performance in pharma and medical devices, you can download your copy here: https://lnkd.in/e8mmKH47 or to learn more about the eBook, listen here: https://lnkd.in/e8X_YuXz

Creating a strong #MarketAccess strategy for your medical benefit drug can be tricky. Our free ebook offers tips on ensuring a favorable status, keeping payer policies and clinical pathways aligned, and determining when contracting is needed. Download the ebook now to discover the five crucial steps your organization should take to establish a firm foundation for your commercialization journey: https://ow.ly/PZjM50Rrg95. #MedicalBenefitTherapy #MedicalBenefitTherapies #CommercializationStrategy #HCPs

Creating a strong #MarketAccess strategy for your medical benefit drug can be tricky. Our free ebook offers tips on ensuring a favorable status, keeping payer policies and clinical pathways aligned, and determining when contracting is needed. Download the ebook now to discover the five crucial steps your organization should take to establish a firm foundation for your commercialization journey: https://ow.ly/Ff9O50Rrgo2. #MedicalBenefitTherapy #MedicalBenefitTherapies #CommercializationStrategy #HCPs

Creating a strong #MarketAccess strategy for your medical benefit drug can be tricky. Our free ebook offers tips on ensuring a favorable status, keeping payer policies and clinical pathways aligned, and determining when contracting is needed. Download the ebook now to discover the five crucial steps your organization should take to establish a firm foundation for your commercialization journey: https://ow.ly/h7RZ50Rrgn8. #MedicalBenefitTherapy #MedicalBenefitTherapies #CommercializationStrategy #HCPs

When #medicaldevice or #biopharmaceutical investigational product can cost tens of thousands, if not hundreds of thousands, of dollars, optimizing the #clinicalresearch #supplychain is paramount. Thanks, Ian Davison, for sharing best practices and strategies on cost-effectively managing supplies.

Creating a strong #MarketAccess strategy for your medical benefit drug can be tricky. Our free ebook offers tips on ensuring a favorable status, keeping payer policies and clinical pathways aligned, and determining when contracting is needed. Download the ebook now to discover the five crucial steps your organization should take to establish a firm foundation for your commercialization journey: https://ow.ly/8Mi250RrfLG. #MedicalBenefitTherapy #MedicalBenefitTherapies #CommercializationStrategy #HCPs

Creating a strong #MarketAccess strategy for your medical benefit drug can be tricky. Our free ebook offers tips on ensuring a favorable status, keeping payer policies and clinical pathways aligned, and determining when contracting is needed. Download the ebook now to discover the five crucial steps your organization should take to establish a firm foundation for your commercialization journey: https://ow.ly/cvpN50RrfO3 #MedicalBenefitTherapy #MedicalBenefitTherapies #CommercializationStrategy #HCPs

Whether you are working on a labeling project or in the medical device industry - this eBook is a must-read. Dive in for expert insights and tips to streamline your labeling process. Click the link below to access the guide and optimize your labeling strategy today! 👇 Read the guide here: https://lnkd.in/eggimb_q #MedicalDevices #Labeling #RegulatoryCompliance