Schlafender Hase

Soaring regulatory demands: are medical device suppliers ready? The global medical devices market is due to exceed $886 billion in value by 2032. As devices become more critical to patient outcomes, regulators’ quality and safety expectations and associated controls are increasing. But how well prepared are suppliers? We recently commissioned independent research to find out. The 2024 study, among 202 regulatory professionals at Class 2 and 3 medical device companies in the EU (Germany) and North America (the US), highlights a number of challenges vying for attention, and assesses device suppliers’ current state of regulatory readiness. The full report can be accessed from the link in the comments.

Navigating the Rising Scrutiny in the Medical Device Sector 🔍 The medical device industry is under increasing regulatory pressure, and adaptation is crucial for success. A recent article by Mike Baird and Peter Muller in MedTech Intelligence explores how companies are responding to these challenges. Read the full article here: https://lnkd.in/eu-QHYFK #MedicalDevices #RegulatoryAffairs #Compliance #MedTech

Bringing a new drug to market involves significant investment and risk. To maximize sales during the exclusivity period, it's crucial to be launch-ready as swiftly as possible. In this article, Mike Baird talks structured content and its pivotal role in product labeling. Learn how this approach can enhance compliance, readability, and efficiency while minimizing errors and saving valuable time. ✅ Discover the key benefits of structured content. ✅ Understand best practices for implementation. ✅ Ensure your product is ready to hit the market seamlessly. Link provided in the comments. #StructuredContent #ProductLabeling

Have you ever considered the potential consequences of a seemingly small labeling error in the pharmaceutical industry? In the article, Vineed Ravindranath dives into the often-overlooked yet critical issue of labeling errors and their profound impact on patient safety, regulatory compliance, and overall industry integrity. Link in the comment section. #labelingerrors #pharma

In life sciences, AI and machine learning (ML, a sub-field of AI) are making waves across the industry, from drug discovery to marketing. So, what does this mean for creating and managing promotional material? “AI seems to be everywhere now. Looking around at some of the claims, it also seems to be able to do just about anything,” says Mike Baird, Director of Product Management at Schlafender Hase. “But, particularly in the pharma space, we know that’s not quite the reality. The potential, however, is enormous, and this is currently being recognized across industry and by regulatory bodies."

Exciting news! RAPS Western Canada Chapter is hosting an in-person event at the British Columbia Institute of Technology's downtown campus with key regulatory players from the Canadian MedTech ecosystem. Get all the details below.

TVT is the go-to tool for regulatory affairs 🙌 How incredible it is to see TVT listed as one of the skills needed in these regulatory affairs jobs descriptions, highlighting its important role in keeping accuracy and compliance high in the field. #regulatoryroles #regulatoryprofessionals 

📢 Medical Device Report: How Are Compliance Strategies Evolving? As devices become more critical to patient outcomes, global regulatory demands in the Medical Device industry are increasing - but how are regulatory professionals adapting to the rising demands? New research has assessed how well manufacturers, and their regional or national partners are managing the rise of regulatory requirements. The study (commissioned by Schlafender Hase in June 2024), with 202 regulatory professionals in the EU (Germany) and North America (the US), highlights the number of challenges currently competing for attention and investment and assesses device companies’ current state of regulatory readiness. Get a copy of the full report here: https://lnkd.in/ewYFXQ2v

🚀 Enhance Your Regulatory Affairs Workflow with TVT! 🚀 By implementing TVT - Text Verification Tool, Regulatory Affairs teams can achieve significant improvements in their proofreading processes: ✅ Reduced Proofreading Workload: Only one person is needed to proofread, freeing up resources for other important tasks. ✅ Peace of Mind: Ensure your labels are accurate and safe for patients, reducing stress and enhancing confidence. ✅ Reduced Correction Cycles: Spend less time on corrections and more time on other critical activities. ✅ Improved Document Consistency: Achieve uniformity across departments, eliminating misprints and preventing recalls. Read the full article at the link in the comment section.

Important Update for Canada's Natural Health Products Industry 🌿 The natural health products (NHP) sector in Canada is rallying together, urging Ottawa to reconsider the upcoming changes in labeling regulations. As highlighted in the latest article by Canadian Grocer, industry leaders believe these regulations could impose significant challenges and costs, potentially stifling innovation and access to these vital products. Read the full article to get all the details and understand the implications: https://lnkd.in/erkM48qB #labeling #regulations