Risk is defined as the potential hazard, harm or side effect of an activity. Almost all activities come with some or another form of risk, which needs to be mitigated or eliminated. Risk management…Continue
Started Oct 17, 2017
IntroductionHandheld devices are light-weight and compact devices that can be operated holding it in your hands. Handheld medical devices are available for medical information, used by physicians,…Continue
Started this discussion. Last reply by Arnold Brame Aug 16, 2014.
Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.
The FDA’s process validation requirements are set out in its general principles of Process Validation.…Continue
Posted on December 10, 2018 at 7:02am
This is how the current-day situation of administering medical care runs: in the event of a medical need, the patient or someone attached to her is expected to sense the difficulty and call up the medical center to which the patient is attached. Help arrives after this is done. The medical practitioner may come over and attend to the patient at her location if the situation permits. Or else, the ambulance has to be called. All this has to done during what is called the Golden Hour: the most…Continue
Posted on November 29, 2018 at 6:19am
ISO 13485:2016 describes a process approach to Quality Management Systems for Medical Devices. This 6 -hour virtual seminar will help you to understand the process approach and develop an effective Quality Management System (QMS) for Medical Device Companies. A well-structured QMS meets the requirements of the Quality System Regulations and is both effective and efficient. The regulations require that manufacturers “establish and maintain a quality system that is appropriate for the…Continue
Posted on November 26, 2018 at 7:38am
A slew of updates to existing medical device and diagnostics (MD & D) regulations is on the cards. Medical device and diagnostics is a field that keeps changing every now and then. But what is different this time is that the industry is up against a series of updates, not just from one regulatory agency, but from a multitude of agencies and standards: FDA, EMA, ISO 13485 and ISO 11607, the last of which is about packaging for terminally sterilized medical devices.
Posted on November 22, 2018 at 6:37am