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?
Fill out the simple form to download the white paper with answers from DDL's technical experts!