In ISO 13485, a risk-based approach is a cornerstone for ensuring the effectiveness and compliance of a Quality Management System (QMS). This approach means that actions, controls, and evaluations be proportionate to the risks associated with specific processes,...
How to Complete FDA Annual Facility Registration: A Step-by-Step Overview This video highlights the step-by-step process for completing the FDA annual facility registration, a mandatory requirement for medical device businesses operating under FDA jurisdiction. The...
Are Supplier Audits Required? No Neither ISO 13485 nor FDA 21 CFR explicitly require supplier audits, although supplier audits are one mechanism of qualification. The requirements established in FDA and ISO rules are: • Companies must define evaluation and selection...
Summary of the issue: FDA announced new actions to strengthen the safety and effectiveness of Laboratory Developed Tests (LDTs) through stricter regulations and targeted enforcement. Increased FDA Oversight: The FDA is actively working to ensure the safety and...
In case you haven't heard... The FDA has issued warning letters to two Chinese firms regarding data quality and integrity concerns. The agency is particularly concerned about the reliability of data used in medical device submissions. As a result, the FDA will not...
Quite a few LDT companies are in the Anger and Denial phases, while some have progressed to Bargaining. The companies that are poised for success though are already in the Acceptance phase and moving forward with developing their QMS. It is likely that the final rule...
Did you know we can help with Amazon FBA regulatory review issues? Recently, there has been an increase in inquiries related to Amazon flagging or removing health-related products and medical devices due to regulatory concerns. This uptick in issues aligns with the...
In recent years, a significant trend has been emerging in the healthcare landscape. Medical devices, traditionally seen as secondary tools or adjuncts to therapeutic interventions, are increasingly becoming primary treatments for conditions that were once managed...