Developing a Mobile Medical Device? FDA Is Watching
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
Tag Archives: regulatory compliance
3-D Printing: Forgotten by the New EU Medical Device Regulation?
The new European Regulation related to medical devices – as adopted by the European Union (EU) Council on 5 April 2017 – does not provide 3D printing with a specific status, raising questions regarding the regulations applicable to this medical innovation.
Is Your Establishment’s Website Problematic?
Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals.
Mistake Proofing
Mistake proofing is used in product, process, and service design and development as well as in ongoing operations and improvement applications. The goal with mistake-proofing is to find and correct mistakes, errors, or omissions as close to the source as possible, when the mistakes cost less to correct than if found later.
CAPA Corner: The Case of the Defunct TV
A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.
A root cause investigation may be formal or informal. Things happen, at work, at home, anywhere. The investigation methodology remains the same. Only the level of documentation changes to fit the situation.
Step 4 – Test Possible Causes
We now test the possible causes against the facts in the IS / IS NOT Diagram to see which ones make sense. This is where the investments made in defining the problem and getting the facts pay off!
Step 3 – Developing a List of Possible Causes
The third step of the investigation is to develop a list of possible causes. All too often investigators stumble at this point as they rely solely on the fish-bone diagram.
Step 2 – Another Key Investment for Success with a Root Cause Investigation
In this third of a series of articles on conducting a root cause investigation, we explore a second key investment every investigator should make: assuring you have the facts! Unfortunately, investigators are often under tremendous pressure to complete the investigation and assume the information they have is entirely correct. As a result days, or weeks, are wasted going down the wrong path.
Step 1 – Key Investment for Success with a Root Cause Investigation
In this second of a series of articles on conducting a root cause investigation we explore a key investment every investigator should make: understanding the problem before defining a solution! Unfortunately, investigations often begin by brainstorming possible causes and prioritizing them for further analysis – leading to a trial and error approach resulting in a prolonged, expensive, and often failed investigation. With Step 1 we try to truly understand the performance problem.
MHLW MO 169 – Chapter 2/Section 6 – Corrective Action
A corrective action procedure requires a significant amount of intelligent thought to ensure all aspects required of an effective corrective action process are captured. Plan ahead and incorporate the preventive action requirements (Article 64) into the corrective action procedure; thus, creating a CAPA procedure.
