1-888-310-4540 (main) / 1-888-707-6150 (support) info@spkaa.com
Select Page

Integrating Medical Device Product Development with the Quality Management System

A critical business challenge for medical device manufacturers as they scale is getting products to market quickly while supporting existing products and meeting FDA Quality System Regulation (21-CFR-820) requirements. To achieve this effectively, Product Development must be integrated with a Quality Management System.

Let’s look at a typical business scenario:

Complaint Scenario

Consider how many different workflow processes and were touched in this one example. How much time was spent searching for information in different systems?  How many people were required to key in information manually into multiple tools?

Siloed processes implemented with point solutions inevitably fail to scale. No single point solution suite can meet 21-CFR-820 requirements completely as they ignore critical interactions between product design, quality and manufacturing:

Siloed Point Solutions

As disparate data stores for CAD files, DHFs, DMRs, CAPAs, NCRs, to name a few, grow rapidly, they become increasingly difficult to migrate and integrate.

This increases the risk of adverse business impacts like delayed product launches, product recalls, FDA 483s and warning letters and we hear:

  • Engineers are spending more time on paper work than product design!”
  • “Pulling documents for an FDA audit or a 510k submission is a nightmare!”
  • “We are spending more and more on IT tools but we still can’t find the right information!”

These issues can be mitigated by adopting a comprehensive Product Lifecycle Management (PLM) solution that spans the entire product development process as well as most of the quality systems processes.  Additionally, end-to-end PLM solutions reflect industry best practices thus helping to increase the organization’s process maturity.

Next Steps:

Latest White Papers

Atlassian Cloud: Understanding Zero Trust Security

Atlassian Cloud: Understanding Zero Trust Security

Where To Start & Why It Matters What is the Atlassian Cloud Zero Trust Security model? Well, for decades, enterprise security controls were built to protect a large, single perimeter around a corporation. Often described as castle-and-moat security, This approach...

Related Resources

Top 6 Ways To Improve Your DevOps Journey

Top 6 Ways To Improve Your DevOps Journey

Knowing how to improve DevOps can be challenging. But, creating an integrated DevOps toolchain can set organizations apart from the rest. This is because having a well-defined business DevOps journey can reduce errors, improve collaboration and drastically increase...

How To Complete Computer Systems Validation (FDA)

How To Complete Computer Systems Validation (FDA)

What is Computer Systems Validation (CSV)? Additionally, why does the Food & Drug Administration (FDA) require them for the Medical Device industry? More importantly, how can CSVs be efficiently completed and managed? Let’s explore why you can’t skip that...

Why Process Automation Is Critical For Engineering

Why Process Automation Is Critical For Engineering

Process automation releases your engineers for the work their brains are intended for. That work is creativity and problem-solving.  By implementing process automation, you improve the team’s morale. Firstly, they get more focus time for deep work and designing better...