DDL has received many questions from medical device manufacturers and package engineers regarding the ISO 11607-01 standard. Questions such as the following:

 

1) Is it necessary to re-do previous validations to comply with the new standard?

 

2) Is it a recommendation or a requirement for testing to be conducted on a product produced at “worst case” parameters not at nominal?

 

white_paper2Fill out the simple form to download the white paper with answers to all 11 questions from DDL's technical experts!