Question
Brian O'Connell BSc MSc 6ΣGB-13 Plus experience
Senior Consultant at KPC International
November 2015
All, A Big Trend I notice in the Pharmaceutical & Biopharmaceutical Industry is the growing importance of Data Integrity. What is the consensus of the group of the focus of the FDA & other Regulatory agencies on Data Integrity for Medical Dev...
ISO 14971 is under systematic review. This means that Nationals Committees will vote if the standard will be reconfirmed, revised, or withdrawn. If you have any comments the use of the standard and suggestions for modifications, I would urge to parti...
With the changes in ISO13485 authorizing notified bodies to perform unannounced audits at what you have identified, or the NB believes, to be critical elements in the value chain. What a boon to NB’s they get to charge us for the cost of audits at ou...
Healthcare today is reactive, retrospective, bureaucratic and expensive. It's sick care, not healthcare. This post is about why the $3 trillion healthcare system is broken and how we are going to fix it.Exponential Medicine: Healthcare Is Broken, Her...
Conventional wisdom has it that the United States is still the strongest player in the medical device industry. It is striking though, how many top medical device companies are headquartered in Europe: Medtronic (Ireland), GE (Healthcare division is ...
The acronym DMAIC stands for: 1) Define, 2) Measure, 3) Analyze, 4) Improve, and 5) Control. I am suggesting the use of these 5 steps to target implementation of process risk controls to prevent complaints.Step 1 (Define) - Identify the most likely c...
FDA Software Validations Are Tied to Manufacturer’s Implementation | iBASEtA very common misunderstanding of this validation requirement is that FDA compliance can be met by having their software vendors “validate” the software they are selling.sourc...
American comedian Stephen Colbert hilariously described the AspireAssist, a new weight loss solution for people with obesity. "Friends, like a lot of you I struggle to keep fit and eat right.... All I ask is that there's a way to take off the pounds ...
Hi Medical Devices Group,I would like to request a bit of advice. My Dad is 87 years old and he is pretty hard of hearing. His left ear is a lot worse than his right. We have a very expensive pair of in-ear hearing aids for him but he hates them and ...
Dear all, I have a question about RUO and IUO labeling in US market.According to FDA guidance "Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only": RUO product is an IVD product that is in the labor...
