Validation advise (ENG)




Validation advise: ISO 11135 - ISO 11137


Producers of Medical Devices in general are well known with all product related issues.
But then another aspect is coming at your path: 

label1



EVERYTHING WHAT IS WRITTEN ON THE LABEL NEEDS TO BE PROVED AND VALIDATED







How can you prove it all as producer?
By following the validation steps conform the current ISO Standards.
This is where I can help you with.



Bioburden
                                                                                                                        VDmax
                                                Microbiological Validation

                                                                                                                                         ISO 11137

             Dose Mapping

                                                                                         Sterilisation Validation
                            Dose Audit


Are these terms you have ever heard of but also think: Yes and now? What do I have to do?

Thanks to years of experience in both Gamma Sterilization as well as Microbiological Validation testing I can give you the answers to that.
Next to that I have solid knowledge of the standards (ISO 11137). My slogan is: You don't need to know everything as long as you know somone who does and is able to help me
Together with you we can make the right approach to set up the complete part of the Microbiological- and Proces Validation at an excelent level.
In the next step we can look for the right partners who can actually perform the testing and processing,

This is a relative small investment which can prevent much misery and loss of money at the moment your Notified Body walks in.




Call or mail for more information.