Laurence Sampson
Medical: A Risk Management Data Model

Medical: A Risk Management Data Model

July 7, 2016
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...
By laurencesampson
< 1 MIN READ
Medical: A Traceability Data Model

Medical: A Traceability Data Model

June 28, 2016
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...
By laurencesampson
< 1 MIN READ
Comprehensive Medical Device Risk Management

Comprehensive Medical Device Risk Management

June 24, 2016
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...
By laurencesampson
< 1 MIN READ
Medical Device System Software Validation Documents

Medical Device System Software Validation Documents

April 13, 2016
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)...
By laurencesampson
< 1 MIN READ
Medical Device Software Validation Terminology

Medical Device Software Validation Terminology

April 4, 2016
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...
By laurencesampson
< 1 MIN READ
Cloud Computing and Software Validation

Cloud Computing and Software Validation

March 18, 2016
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...
By laurencesampson
< 1 MIN READ
An Insight to Truth

An Insight to Truth

February 11, 2016
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...
By laurencesampson
< 1 MIN READ
Medical Device Design Control (Part 3 of 3)

Medical Device Design Control (Part 3 of 3)

April 25, 2015
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-...
By laurencesampson
< 1 MIN READ
Medical Device Design Control (Part 2 of 3)

Medical Device Design Control (Part 2 of 3)

April 3, 2015
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-...
By laurencesampson
< 1 MIN READ
Medical Device Design Control (Part 1 of 3)

Medical Device Design Control (Part 1 of 3)

March 4, 2015
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-...
By laurencesampson
< 1 MIN READ