In this Sterilization Shelf Life Webinar, you will learn how to write a summary technical document (STED) for section 14 of a 510k submission that will also meet the requirements for a CE Marking technical file.
Why you should register for the Sterilization Shelf Life Webinar
The sterilization shelf-life section of submission is not just a paragraph referencing the recognized standards that were applied. Sterilization validation must be completed in accordance with the most recent standard regardless of which market you are seeking regulatory approval in, but the process of reviewing the sterilization shelf life data is much more involved for some processes. You also need to include information a summary of the methods used, the number of samples, a justification for sample selection, acceptance criteria, and a summary of the results.
For FDA submissions, you are not required to submit your complete test reports for sterilization shelf life validation but you must provide a thorough STED or the FDA reviewer will request complete reports. On-site pre-approval inspections are sometimes required while at other times a routine inspection is merely prioritized. For Notified Body (NB) submissions, some of the NBs require an additional audit of sterilization shelf life validations to be conducted by a trained microbiologist.
Shelf-life testing has always been important for EU Technical Files and the testing must be in compliance with ISO 11607-1:2007, but the FDA released a new guidance document on August 8, 2016 specific to device modifications. This new guidance includes new information regarding changes to the shelf-life of a product and when a new 510k submission will be required due to a change in the expiration date of 510k cleared products.
What you will receive for $49
- a recording of the webinar you can replay anytime
- my updated sterilization shelf life template
- the native slide deck for this webinar
The presentation consists of 45 slides and was 47 minutes in duration. All deliveries of content will be sent via AWeber emails to confirmed subscribers.
Q&A
Please submit questions to me by email at rob@13485cert.com regarding the Sterilization and Shelf-Life Webinar.
Sterilization Shelf Life Webinar – $49
In this webinar you will learn the requirements for Section 14 of 510k submissions. You will also learn how to format the content to ensure it also meets the requirements for a CE Marking Technical File.
Additional Resources for 510k submissions
If you would like additional training on 510k submissions or you would like to access Medical Device Academy’s templates, you can purchase all of our templates and 510k webinars on our 510k course webpage.
About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email. You can also follow him on Google+, LinkedIn, or Twitter.