Medical Device Safety and Quality

This page provides blogs, short videos and recordings focused on the trends for medical safety and quality, including insights into risk management, product design, market research, post-market surveillance and regulatory intelligence.

Recent Blogs

Regulatory Survival Guide: FAQs Every Drug and Medical Device Manufacturer Should Know

Drug Label Research, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics, Unique Device Identification

Navigating drug and device regulations isn’t optional—it’s mission-critical. This Regulatory Survival Guide breaks down the complexities of global compliance, from FDA and EU MDR to Health Canada, UDI, and MoCRA. Whether you’re managing submissions or facing upcoming deadlines, use this FAQ to decode key terms, avoid costly risks, and stay ahead with expert-backed solutions like Compliance-as-a-Service (CaaS).

Reflecting on RAPS Euro Convergence 2025: Regulatory Innovation in Motion

Drug & Biologic Product Submissions, Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

Global supply chain shifts can jeopardize regulatory labeling. Learn how LexisNexis Reed Tech helps manufacturers stay compliant through agile, localized labeling solutions.

ESG NextGen Is Coming: Key Milestones, Blackout Dates & What You Need to Know

Drug & Biologic Product Submissions, Life Sciences, Medical Device Safety and Quality, Medical Devices, Pharmaceutical and Cosmetics

As part of ongoing enhancements to streamline data exchange and compliance processes, the ESG NextGen platform is preparing to go live this spring. We’re sharing a quick overview of the key milestones and what they mean for you especially as we approach the submission blackout period from April 12 to April 14, 2025.

How Does Software as a Medical Device Relate to Unique Device Identification?

Medical Device Safety and Quality, Medical Devices, Unique Device Identification

Determining Software as a Medical Device is essential for regulatory compliance. This involves classifying software as a Device Component, Accessory, or Standalone Device, and understanding FDA’s UDI requirements and the implications of software changes on device identification.

EU’s Requirement for Implant Cards Provides Key Information for Patients

Medical Device Safety and Quality, Medical Devices, Unique Device Identification

The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices,...