Risk management in ISO 13485 Written by Dr. Janet Thode on 02 June 2017. Posted in norm ISO 13485 We are sorry... Read more
ISO 13485:2016 vs. ISO 9001:2015 - part 1 Written by Michael Thode on 01 April 2017. Posted in norm ISO 13485 We are sorry... Read more
Costs of a certification according to ISO 13485 Written by Michael Thode on 23 March 2017. Posted in norm ISO 13485 We are sorry... Read more
Risk priority number (RPN) Written by Michael Thode on 04 March 2017. Posted in norm ISO 13485 The term “risk priority number” is used again and again in conjunction with the risk-based approach included in the ISO 13485. I want to explain what the risk priority number (short: RPN) is in this blog entry. Read more