Zimmer Biomet Responds to FDA Form 483
The company stated disagreement with certain aspects of some of the technical CAPA topics, based on perceived misunderstanding on behalf...
Jun 28 2018,
Regulations
Why the Inadvertent Release of Non-Conforming Products is Reportable, Recordable
It is recommended to err on the side of caution in these situations and report the product release, as well...
May 29 2018,
Start Simple: Advice to Effectively Use Statistical Methods in Process Validation
Thorough process development, optimization and control using appropriate statistical methods and tools is recommended to show that processes are stable...
Apr 23 2018,
FDA and Customs Monitoring of International Purchasing: What You Need to Know
The ultimate goal is to ensure that all medical device products manufactured or distributed in the U.S. are both safe...
Apr 06 2018,
Vital Validation Considerations for Your Company’s Next Packaging Project
Common problems that OEMs face during packaging validation include determining what validations are actually necessary, understanding all timelines and costs...
Feb 27 2018,
Medical Device Packaging is Shaped by Increased Regulations
Global unique device identification (UDI) and ISO updates are among the regulations and standards that companies must monitor in the...
Feb 27 2018,
The Medical Device Labelling Process Needs to Start Early in Design Controls
Mislabeled and misbranded medical devices are one of the top three causes for recalls in the United States. Companies can...
Feb 21 2018,
Are You Capturing the Right Inspection Information?
By recording actual results, instead of pass/fail, you can better investigate failures that may occur in production/post-production. This approach also...
Feb 19 2018,
FDA Issues Direct Final Rule to Alter Outdated Requirements on Biologics Inspections
The rule amends that inspections will be risk-based, not biennial....
Feb 01 2018,
UDI: Is Your System Ready for Scale?
UDI requirements have led to layers of regulatory decoding, data collection and dissemination, additional costs and moments of confusion, annoyance...
Jan 31 2018,
FDA Issues First De Novo Clearance Under Orthopaedic Panel
IlluminOss Medical recently received FDA de novo clearance for the IlluminOss Bone Stabilization System to treat pathological fractures. ...
Jan 18 2018,
The Brazilian Market: A Regulatory Overview for Orthopaedic Products
Most Brazilian surgeons use imported products, making the country attractive for international companies. Placing products on the market means creating...
Jan 05 2018,
FDA Releases Priorities for 2018
Among the Agency’s 2018 priorities is an alternative, fast-track 510(k) pathway for certain devices....
Jan 05 2018,
FDA Finalizes Additive Manufacturing Guidance
FDA published its guidance on additive manufacturing technical considerations, outlining the Agency’s long-awaited position on use of the technology for...
Dec 06 2017,
CMS Finalizes Joint Bundled Payment, Outpatient Payment Changes
The Centers for Medicare & Medicaid Services (CMS) made changes to the bundled payment model for Comprehensive Care for Joint...
Dec 06 2017,