Latest Articles
Explore our most recent posts below, and be sure to check back often for new content that can help you streamline your operations and achieve success in the competitive medical device market.
What does GMP-Exempt Mean?
Beyond the 510(k): Why "GMP-Exempt" Status Matters in Medical Device Classification Navigating the world of medical device regulation can feel like deciphering a complex code. You're likely familiar with device classes (Class I, II, and III) and submission types like...
Your Data, Your Responsibility: FDA’s Warning on Third-Party Lab Failures
Data Integrity Crackdown: FDA Tightens Oversight on Third-Party Lab Testing Medical device manufacturers received a serious wake-up call this year: the FDA is rejecting study data from two Chinese labs after uncovering widespread data integrity violations. The message...
Risk Inputs in ISO 13485
ISO 13485 Made Simple: Using Risk to Guide Your Quality System ISO 13485 requires that medical device companies use a risk-based approach in their quality systems. That means the more risk something poses to product safety or compliance, the more carefully it needs to...
How-to: Facility Registration
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...
Value of Supplier Audits
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...
LDT and IVD Info Hub
!!UPDATE MAR 31, 2025 - The LDT Final Rule was overturned in court!! Get more info from ACLA ---------------------- From October 2024 ------------------------------- Summary of the issue: FDA announced new actions to strengthen the safety and effectiveness of...
Warning Letters
FDA Cracks Down on Unreliable Lab Data: What Device Firms Need to Know Medical device manufacturers received a serious wake-up call this year: the FDA is rejecting study data from two Chinese labs after uncovering widespread data integrity violations and the message...
LDT 5 Stages of Grief
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...