Implementing a CAPA system is required by the FDA for Medical Device Manufacturing companies selling equipment within the US.
Will The Medical Device Industry finally get a break or just encounter another roadblock? It is clear to all involved in this industry, that the regulatory approval process has become longer and more arduous over the past couple of years. The proof of that statement is that better than half of the 510k with clinicals […]
There are a multitude of complex issues facing the medical device contract manufacturing industry today. Consistent with all businesses in our country, there has been some level of “impact” from the decline of the economy since 2008.
Creative new concepts that launch medical device companies from concept to market have addressed the paradigm shifts in medical device funding; such as short and quick utilization of venture money and the use of a certified manufacturing facility on a rental basis. Conventional venture capital investments in medical device start-ups may no longer be filling […]