Sterilization Expert Stresses Importance of Biocompatibility, Endotoxins, Planning
Recent updates to standards and regulatory guidance have made sterilization processes more complex....
Oct 05 2018,
Regulations
How to Respond to FDA Inspection Observations, Even Those You Dispute
Martin Browning from EduQuest provides insight on responding to Form 483 observations: "It’s critical to show FDA that you are...
Oct 04 2018,
25 Considerations for Companies Seeking Clarity in Design Controls
OEMs must be aware of and comply with design control requirements included in 21 CFR, Part 820. Unsafe, ineffective devices...
Sep 24 2018,
How the European Union’s MDR Will Impact Your Company’s Supply Chain
OEMs must engage partners in conversations about the information needed from each party for Medical Device Regulation in order to...
Aug 02 2018,
FDA Responds to Additive Questions on 510(k) Submissions, Reusing Powder, Testing
An agency representative, and experts from ASTM, DePuy Synthes, and SME, talked additive regulatory issues at OMTEC 2018. Among the...
Aug 01 2018,
Think Different About Management Reviews
When done correctly–with preparation and an energized approach–these reviews can complement strategic planning and measure the effectiveness of your QMS...
Jun 28 2018,
Making a Device Design Change? Document These Critical Steps
No matter where you are in the design process and no matter your internal procedures, control and documentation of design...
Jun 28 2018,
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,
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,