Compliance is a critical and mandatory requirement for businesses that design and deploy certain kinds of medical imaging devices. These businesses are directed in the US by a formal legal entity, the FDA, where product life-cycle management for such devices is controlled by federal laws; view an overview of the 21-CFR Part 820 law, as well as the FDA's details page.

Methods & processes may be directly derived from these laws; examples include such items as a new product introduction process (NPI), a disciplined phased product development process (PRD) and CAPA (see below) as well as others.

Businesses such as these must use a structured approach for compliant product management:

The red items (highlights) are listed below; click either the image or the link for a better view?
     The list starts with the item that is at the top right-hand corner of the image…

Highlights
1.

The "Customers & Regulatory Agencies" highlighted box (top right) is the primary root (or the start point) of a product cycle, where the identified groups each bring data and information into the business, feeding the annual planning process (WWPP) and the new product introduction (NPI) cycles.

Requirements are the next phase of the cycle and form the "essential definition" of a product, covering all aspects of the system in a formal, approved document that is under revision control.

View expanded and more detailed definitions of this term here and here.

The "Plan, Design, Production, Purchasing and Receiving" box (PDPPR) that follows in the cycle is a conceptual encapsulation of the various areas of a business…

Verification (definition) is a critical step in the sequence, and has bi-directional execution

When moving forwards (towards Monitoring & Measuring), V&V gates product release.
When moving back to PDPPR, V&V is part of the CAPA process.

Products are essential–without a successful product, income ceases, the cycle dies & the business suffers from the "inconvenience" of huge profit gaps!

CAPA is the acronym for Corrective and Preventive Actions, the core of compliance issue resolution.

As an example of the significance of a miss here, GE's OEC business was shut down (news article; scroll down to the "GE Radiology Units Shuttered by FDA" section) for a very, very long time in 2007 from a repeated failure to comply with previous CAPAs…not a great idea.

View the legal definition of CAPA here and a summary here; the term "QSIT" is the FDA auditors guide.

A Quality Management System (QMS) is the backbone to allow a business to achieve compliance; view a sample QMS to see how a QMS might be constructed upon the 21CFR clauses.

The opening statement also establishes the overall intent:

<company>, part of <corporation>, strives to observe key attributes of the relevant medical world more clearly, thereby helping its customers to better understand many attributes of disease, and how such diseases are diagnosed & treated to help allow individuals to live life to the fullest.

Control of QMS Effectiveness is the gate that permits or stops the cycle from moving forwards.