Day

October 25, 2003
Guidance for Industry and FDA Staff Providing Regulatory Submissions in Electronic Format — General Considerations.  Document dated Oct 22, 2003. This guidance focuses on use of pdf files. It provides many specific requests in construction of the pdf for suitability for electronic submissions. These include resolutions, pagination, preference for digital instead of scanned source documents....
Read More

Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.