Coming Soon!  This is a place where you can purchase medical device regulations webinars, in-person training, standards, procedures, forms and guidance documents.

 

Usability Validation SOP

The Usability Validation SOP describes the activities necessary to demonstrate that the device conforms to User Usability requirements and intended uses. Usability Validation is very different than device validation(11 pages + 4 forms)

Language: English
Product Type: Digital SOP
Provider: Med Device Advisors
Price:  US$200

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

  • Speaker: John R Godshalk
  • Product ID: 704806
  • Duration: 60 Min

This recorded webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity

Supplier Quality Agreement

This SOP explains when a Quality Agreement between a company and a supplier or contract manufacturer is needed and the necessary content (6 pages)

Language: English
Product Type: Digital SOP
Provider: Med Device Advisors

Price:  US$150