There can be a multitude of reasons why troubled projects are delayed in being abandoned or brought under...
510k
Industry Reaction to 510(k) Exemptions
Earlier this year, the Department of Health and Human Services proposed exempting 84 types of Class II devices from...
The Types of 510(k) Submissions
For the most part, everyone in the medical device industry is familiar with the term “510(k)”, but not many people...
Regulatory Change Assessment
Making a change to the design or the manufacturing process of your product that is already out in the field? You have...
510(k) Vs CE Mark
A 510(k) is the most utilized regulatory pathway to market a medical device in the US. For a device of the same level...
The New, New 510(k) Paradigm: Special 510(k)s
The Special 510(k) program was established to create a more efficient review process (30 days instead of the 90 days...
ISO 14155:2019 … Changes to Expect
ISO 14155 [Clinical investigation of medical devices for human subjects – Good clinical practice], as the name...
What Should Your 510(K) Include for Software Contained in A Medical Device?
With the increasing use of software in every medical device, it is very important for every manufacturer to know how...
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