ISO 13485:2016 – Keep the Quality Agreement Separate to the Supplier Agreement [Video]
It is recommended to keep the Quality Agreement separate from the Supply Agreement and...
Course Code: ELM-806
by: Don Rackham
Micro-learning
Medical Device Reporting Timelines for the US
Specific Timelines Medical device reporting timelines are very specific depending on the organization’s relationship...
Course Code: ELM-807
by: Don Rackham
Micro-learning
The Importance of Allowing Adequate Time for Design and Development Inputs | ISO 13485
Adequate time should be given to develop comprehensive design input requirements. Key Elements of...
Course Code: ELM-805
by: Don Rackham
Micro-learning
3 Categories of Design and Development Inputs | ISO 13485
From the URS a variety of input requirement documents may be generated. Typical input...
Course Code: ELM-805
by: Don Rackham
Micro-learning
Overview: Design and Development Inputs | ISO 13485
Just as the DDP needs to be written and reviewed document, the design and...
Course Code: ELM-805
by: Don Rackham
Micro-learning
Design and Development Common Mistakes | ISO 13485
Design Control is Not Product Development One common mistake is to think of design...
Course Code: ELM-805
by: Don Rackham
Micro-learning
Document Approval | Design and Development ISO 13485
One common problem is in many organizations there is a resistance to approve many...
Course Code: ELM-805
by: Don Rackham
Micro-learning
Design Control Basics – ISO 13485:2016
Design control is often a major source of confusion although; with time it has...
Course Code: ELM-805
by: Don Rackham
Micro-learning
Infrastructure Requirements Explained | ISO 13485
Documenting Infrastructure Requirements The organization must document the requirements for the infrastructure needed to...
Course Code: ELM-804
by: Don Rackham
Micro-learning
“Awareness” and the Achievement of Quality Objectives | ISO 13485
Another specific requirement for ISO 13485 is that personnel be made aware of the...
Course Code: ELM-804
by: Don Rackham
Micro-learning