FDA Issues Cybersecurity Draft Guidance, Wants Devices Designed Securely
With the ever-increasing adoption of connected devices, the agency is emphasizing the need for effective cybersecurity.
Tag Archives: documentation
FDA’s Final Guidance Pushes Companies to be Recall Ready
The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.
Products Fail: Four Ways to Mitigate It
This article reviews real-world examples of product failures, presents reasons for these failures and provides potential solutions better governance, collaboration, and data gathering throughout the product lifecycle.
Why Documents and Data Can No Longer Be Treated as Distinct Entities
If teams across regulatory, quality and safety functions—as well as further across the life sciences enterprise—are to be able to think and operate in more agile and dynamic ways to achieve what is necessary, then the way that they generate, manage and store documents and data needs to change fundamentally. Regulatory changes (e.g., towards data-driven submissions activity, more dynamic item/label tracking, etc.) are prompting some of this change, but cannot be relied upon exclusively to drive the process improvements now needed.
Data-Document Continuum: Why Life Sciences Transformation Depends on Companies Overcoming Information Silos
Companies within the life sciences industry should rethink how they manage their data and documents.
EU IVDR Weekly Virtual Series Begins March 30
Anyone can read the regulation. The challenge is in how to apply it to your company’s structure and product line.
Medical Devices: Is There Life After Death?
Regardless of the reason for disposing of a medical device or other electronic equipment, the product must be destroyed in a manner in which it can never be reused or identified as coming from your organization. In addition, the resulting materials from the destruction process be disposed of in an environmentally appropriate and regulatory compliant manner.
Why Medical Device Makers Need to Revamp How Products are Manufactured
With digitalization impacting all areas of manufacturing operations, it should come as no surprise that medical device producers must adapt or risk missing the next wave of performance and product improvements.
EU MDR Strategy: How to Effectively Deploy Consultant Partnerships
Achieving EU MDR compliance is considerably challenging for many businesses, which is why they must be discerning when it comes to selecting suitable partners.
How a Requirements Management Solution Helps Keep the Pace with Innovation
During product development, collaboration between software, hardware and quality teams must be tracked and seamless to meet the increasing pace of market demand.
