After over 3 years, the COVID-19 Public Health Emergency (PHE) will end on May 11, 2023, the Biden Administration announced last week.1After 3.5 years of the modified policy to allow for amore efficient path for COVID-19-related medical products to get to market, this begs the question of how it will impact the MedTech world.
Madison Green
EMMA International Consulting Group, Inc. and Thema Announce Strategic Partnership
EMMA International has entered into a strategic partnership with Thema, an Italian based strategic-regulatory consulting company. The goal of this strategic partnership is to expand geographical offerings to companies operating in the life sciences regulated space.
Making Quality Systems Work for You
If your QMS does not have the proper elements, personnel are not appropriately trained, or your firm does not really value the advantages of your QMS, you will likely not reap the same reward.
EU MDR SSCP’s: The Importance of Readability
Among many of the new requirements that EU MDR has introduced, the Summary of Safety and Clinical Performance (SSCP) is certainly one of the more confusing ones for many firms. SSCP’s are required for implantable and Class III devices under EU MDR and is intended to be a public document summarizing important safety and clinical performance information about the device.
QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question
A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?
EU MDR Delays
It is no surprise to anyone in the medical device industry that the transition from EU MDD to EU MDR has seen quite a few hiccups over the past couple of years. The most recent obstacle, however, comes in the form of delays from Notified Bodies. The scale of the bottleneck coming from Notified Body capacity to review EU MDR applications has not been a secret, but a recent industry poll sheds light on the growing concern.
Annual Drug Product Reviews
If you are a drug manufacturer in the US, an Annual Drug Product Review (ADPR) should be familiar to you. ADPRs are exactly what they sound like – an annual review of your drug product based on product batch and product yield, customer complaints, recalls, stability data, and validation data just to name a few. ADPRs should be performed in order to maintain compliance with 21 CFR 211.180 and to be in alignment with the FDA’s Guidance for Industry, Q7A GMP for Active Pharmaceutical Ingredients.[1]
Statistical Process Control for Medical Devices
There is an innate benefit to utilizing statistical techniques in any manufacturing process, but even more so for...
Project Management in the Life Science Industry
Project Management, as it is classically defined, can be described as “…the use of specific knowledge, skills,...
Proctor & Gamble Cosmetic Recall
On Friday, Proctor & Gamble announced a voluntary recall of several of their aerosol dry shampoo and...
The FDA and CBD
As more and more states legalize the use of medicinal and recreational marijuana, and as more consumer...
Global Regulators publish Good Machine Learning Practices (GMLP)
It is no secret that AI/ML medical devices are under a special spotlight by international regulators this...
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