10 Things You Should Do Before You Validate Your Next Package

Before you set out to validate a medical device package design or process, you have to do your homework. You need to understand what is critical so you build the proper foundation. Key steps include understanding regulatory requirements, familiarizing yourself with ISO 11607 for sterility guidelines recognized by both the EU and FDA, and involving packaging professionals early in design to ensure compatibility and reduce future risks. If your company is marketing a sterile medical device, your goal is to develop a sterile barrier system and avoid a breach of that system. This DDL white paper offers 10 points to consider before beginning any validation effort.

---