The DMR is nothing more than the recipe (a.k.a. secret sauce) while the DHR is documented evidence of compliance.
There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.
As standalone software becomes increasingly sophisticated, a number of regulatory bodies have begun to draft separate guidelines to ensure quality control, expedite product approval, and improve patient access to new technologies.
There really is no excuse for receiving a Form 483 observation for management review.
Simply stated, an inspection needs to add some value; otherwise, what’s the point?
By adhering to FDA recommendations and leveraging the expertise of proven cyber testing methods, manufacturers can tackle known cybersecurity issues today while also attempting to anticipate concerns that may lie ahead.
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
If a device establishment is going to invest significant time and money into building a cleanroom or a controlled environment room, it makes zero sense not to perform proper monitoring of the environment.
Technology should streamline the healthcare process for both patients and clinicians.
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.