Schlafender Hase

What a year it has been! 🎉 From exciting product launches and big moves (hello, new office! 👋) to unforgettable events and everything in between - 2024 has been a whirlwind of growth, fun, and hard work! Relive the highlights, the laughs, and the moments that made this year special in our Year in Review video! 🎥 Here’s to another incredible year ahead; bring on 2025!

The Rising Challenges of Packaging and Labeling in the Medical Device Industry. As global regulations around tracking and supply chain transparency become more stringent, the task of producing compliant packaging and labeling for medical devices has never been more challenging. A 2024 study commissioned by Schlafender Hase surveyed 202 regulatory professionals at Class 2 and 3 medical device companies in Germany and the US to explore these challenges. The findings are striking: ◾Translations are a major hurdle, with 65% of respondents finding them challenging to manage. ◾Barcodes pose difficulties for 61% of respondents, highlighting the complexities of ensuring accuracy and compliance. ◾Graphics, including symbols (e.g., device sterilization icons), are tough to handle for 60%. ◾Tables also present significant challenges, cited by 59% of respondents. ◾Even getting the text right remains an issue, with 54% finding this aspect challenging. As the demands on packaging and labeling continue to grow, the need for robust processes and tools to manage these elements effectively is more critical than ever. How is your organization addressing these challenges? Download the report: https://lnkd.in/efrRCfG3 #MedicalDevices #RegulatoryAffairs #Packaging #Labeling

Streamline Your Artwork Approval Process with TVT 🚀 Looking for faster, more efficient artwork approvals? Here’s what you can expect from TVT: 1. Fast Turnarounds & Parallel Approval: Save time by reducing manual work—approvals happen in minutes, not hours. 2. Seamless Collaboration: Centralized checks, easy annotations, and a solid audit trail simplify feedback and boost collaboration. 3. Fewer Revisions & Correction Cycles: Get it right the first time with TVT, reducing time spent on revisions and corrections. 4. Improved Version Control: Ensure no post-approval changes go unnoticed with comprehensive document comparison. 5. Reduced Risk of Non-Compliance: Designed for regulated industries, TVT is trusted by leading pharma companies and regulatory bodies. 6. Easy Upscaling & Integration: Whether on-premises or cloud-based, TVT fits right into your digital workflow. 7. Fast ROI: With intuitive design and rapid implementation, TVT delivers a quick return on investment. #ArtworkApproval #Compliance #Pharmaceuticals #RegulatoryAffairs #Labeling #Automation #ROI https://lnkd.in/eRbcFhYe

The Schlafender Hase team in Frankfurt, came together last night for a lovely holiday celebration. The evening was filled with laughter, delicious food, and wonderful company—a perfect way to celebrate the season!

We wanted to take a moment to recognize the incredible work of our pharmaceutical and medical device customers. Every day, these organizations strive to create treatments and devices that improve and save lives. #Grateful

🔍 Key Lessons from 2024: Preparing for the Future in the Medical Device Industry Reflecting on the past year, regulatory professionals at Class 2 and 3 medical device companies in the EU and the US have gained valuable insights to carry forward. A 2024 study commissioned by Schlafender Hase revealed the top five lessons learned: ◾Greater Investment in Company Culture (35%) – Building a strong, supportive culture has become a top priority. ◾Bolstering Resources/Recruitment (34%) – Ensuring teams have the right talent and resources is crucial for meeting regulatory demands. ◾Emphasis on Wellbeing (33%) – Focusing on employee wellbeing is essential for maintaining productivity and morale. ◾Investment in Technology (33%) – Leveraging the right technology is key to staying ahead in a rapidly evolving industry. ◾Increased Focus on Education and Training (32%) – Continuous learning and development are vital for keeping teams equipped to navigate new challenges. As we move into the coming year, these lessons will be instrumental in shaping strategies and ensuring continued success in the face of evolving regulations and market demands. How is your organization applying these lessons? Download the full report here: https://lnkd.in/eHHEcaTH #MedicalDevices #RegulatoryAffairs #CompanyCulture

Meet the Trainers Behind the New TVT e-Learning Portal! 🎥 Get to know Giuseppe Napoli and Yuliana Wong, the dedicated experts guiding you through our redesigned TVT e-Learning experience! With years of expertise and a commitment to making learning accessible and engaging, Giuseppe and Yuliana are here to support your journey every step of the way.

In November we introduced TVT 12 - a groundbreaking update to our document verification software designed to set a new standard in compliance and efficiency. From improved style checks and smarter search functionality to simultaneous multilingual spell check and expanded dictionaries, TVT 12 is here to enhance your workflow, reduce errors, and support seamless document review. Curious to learn more about what TVT 12 can do for you? Dive into our latest blog to explore the full list of updates and how they’ll transform your document verification process. 🔗https://lnkd.in/eM5ZTRrX

Discover impactful insights from healthcare leadership! Hasnaa Fatehi, PhD, RAC (Devices), Founder and CEO of QARALOGIC, shares her expertise in an engaging discussion hosted by our very own Vineed Ravindranath, Account Executive at Schlafender Hase.   What we’re diving into: ▪️ The unique value boutique consultancies bring to healthcare. ▪️ Hasnaa’s leadership journey and the lessons she’s learned as an industry pioneer. ▪️ How to stay agile and innovative while navigating regulatory challenges. Don’t miss this opportunity to gain insights from two experienced professionals.   Looking to learn more about QaraLogic? We’ve included Hasnaa’s company information in the comments

Managing compliance with medical device labeling regulations is a complex, ongoing process that requires a strategic approach. In the larger picture, your company should have effective quality management Standard Operating Procedures (SOPs), including the validation of labeling, post-market surveillance (an important part of the MDRs), and document update workflows. Our Checklist for Managing Compliance with Medical Device Labeling Regulations is designed to help you navigate this intricate landscape with actionable steps to stay compliant and optimize your labeling process. compliance and streamline your labeling workflow. Download the checklist today. https://lnkd.in/exuRvRZ7 #MedicalDevice #LabelingCompliance #RegulatoryAffairs