In our previous blogs I described [blog 1] and [blog 2] the regulatory requirements related to product risk and the elements required to build a database for use in the risk management system. The fo…
To read the first blog in this series, Comprehensive Medical Device Risk Management, please click here.
The first task of any product development process is generally to discover, define and l…
One of the more difficult system development tasks in the context of a new medical device is how to organize and develop the product risk management strategy. When contemplating how to construct a sy…
As I discussed in my last blog, software used as a platform to support the manufacture of product or in the product quality management system (QMS) must be validated (as required by 21 CFR §820.70(i)…
To read the first blog of this series, Cloud Computing and Software Validation, please click here.
I was recently speaking with a colleague about the significant software validation burden on life s…
One of the more difficult problems associated with the introduction of cloud computing is a constant need for software validation of platform software changes.
Many of Polarion’s clients use our sof…
For some time document management, PLM, and ERP systems have been banging the drum of becoming the company single source of truth.I would like to take a different approach and discuss the data…
Medical device product development work is a highly integrated, and regulated process. Implementation of a requirements tracking solution requires attention to a variety of nuanced topics. In this 3-…
