Activities

The activities that will be done for validation are defined. Coordination with a test lab is
critical to timely completion. With the latest updates to the standard (3rd edition of IEC
60601), a substantial amount of risk assessment must be provided to the test lab. Further,
activities will also include clinical trials – a costly and timely effort.

Responsibilities
As the old saying goes, if nobody is responsible, it won’t get done. Establishing who is
responsible for each activity provides the communication for expectations.

Strategies, Tools, and Methods

Many times, the strategies, tools, and methods have a profound impact on the activities.
Strategies may include a clinical trial which involves recruiting a specific user population.
Some validation efforts may require specialized tools. These tools may subsequently
require validation – so planning is critical to a timely conclusion.

Test Entry
Test entry / exit criteria needs to be established so it’s clear what the gating criteria is. For
example, in some cases, prototype software may be used to enter test; however, to exit an
activity, the software may need to be formally released.

Many companies say that products can be released (exit criteria) if there are no safety-
critical issues open; i.e., if there are “cosmetic” issues with the product, the product can be
released; but if any of the safety tests fail, the product cannot be released (cannot exit
validation). Some test efforts may require specialized training.

Identifying Problems
Identifying how problems / issues are reported and dispositioned – everyone recognizes
that no products are “perfect.” However, safety or efficacy cannot be compromised.
Typically, issues arising during validation are logged in the company’s issue tracking
system.

Issues are then reviewed by, typically, a board, so that all stakeholders (R&D, quality,
regulatory, etc.) can weigh in on the (potential) impact of the issue.

If all agree that the issue does not compromise safety or efficacy, the board may agree that
the product can be released with the issue. Establishing how issues are reported and
dispositioned in the Plan ensures any issues found during validation are properly handled.
Resources Required
For example, if the strategy for usage validation is to confirm that the device is usable
across the population of users, recruitment of users will be a gating factor for conducting
tests.

This may include, for example, recruiting pre-teen, teenage, young adults, mature adults,
and seniors. Without forethought, this could become a serious delay in the product life.
This may also require some specialized training that must be provided for those resources.

Reporting
This is a concern, especially when activities are spread out across diverse groups. There
should be a focal point for compiling the data and making clear, comprehensive, evidence-
based conclusions from the validation efforts.