Data Integrity & Controlled Areas [Video]
Records should minimally be stored within controlled access.  They may be in a locked...
The Medical Device File Index [Video]
The Medical Device File can be easily accomplished by creating an MDF index.  The...
1 Minute Guide to Design Input Requirements – ISO 13485:2016 [Video]
Adequate time should be given to develop comprehensive design input requirements. Unambiguous Requirements The...
Your 2 Minute Guide to Design & Development Inputs [Video]
Just as the Design and Development Plan (DDP) needs to be a written and...
Your 1 Minute Guide to Document Revision in a Regulated Environment [Video]
The quality system is continually evolving, to address new regulations, new products, the growing...
How the Document Hierarchy Works in a Life Science Environment – With Example [Video]
The document hierarchy is also very important Typically, the way the document system is...
The Reason Why Organizations Resist Approving Design Documents [Video]
One common problem is in many organizations there is a resistance to approve many...
ISO 13485:2016: The Biggest Mistake to Avoid with Dealing with Design Controls [Video]
Design control is often a major source of confusion although; with time it has...
Medical Device Production and the Importance of the Quality Plan [Video]
The quality plan is a document or documents which together specify the quality standards,...
How to Handle Medical Device Non-Conformances [Video]
Typically, a process will be created with a title such as “Control of Nonconforming...