Evolving QA & QC Reporting in the Medical Equipment Industry

Despite the push toward digitization, medical equipment manufacturers are still relying on manual processes that are outdated and inefficient when it comes to quality assurance (QA) and quality control (QC).

News & Updates
 Min read
March 29, 2024

The medical equipment industry is going through digital transformation, with systems and processes becoming increasingly automated and modernized. Despite this push toward digitization, however, manufacturers are still relying on manual processes that are outdated and inefficient when it comes to quality assurance (QA) and quality control (QC). 

Read on to learn why QA & QC reporting needs to evolve and the benefits that come with digitizing and transforming reporting. 

The risks of manual inspections 

Many companies are still using traditional paper- and spreadsheet-style reporting when inspecting medical equipment — a strategy designed for a pre-internet world.

Unfortunately, manual equipment inspection is extremely time and labor-intensive, with reports typically having to pass through multiple levels of management chains before arriving at their destinations. As a result, reports that should take hours to complete often wind up taking days or weeks to pass inspection. 

In addition, manual reports often contain data-entry errors that lead to inadequate inspections. As a result, inspections tend to drag on longer than they should and often require rework. 

The benefits of digitizing reporting 

Medical equipment manufacturers need to move quickly and efficiently during inspections to control costs and meet deadlines. Digitizing reporting allows inspection teams to move faster and more effectively while enjoying the following benefits. 

Streamline troubleshooting and repair

It’s possible to enhance digital reporting tools using detailed graphics, videos, and instructions. This leads to faster and more efficient reporting with fewer mistakes. 

Improve communication

Even with detailed instructions, technicians may still encounter issues that require advanced support or assistance. A digital reporting tool can provide secure, in-app communication for rapid response support and guidance. Improving communication saves time for maintenance teams and eliminates guesswork.  

Share updated regulatory standards

Medical equipment manufacturers need to keep up with an ever-changing list of regulatory standards. Some common examples include ISO 13485, ISO 13485:2016, and CFR Title 21, among others. Manufacturers can use digital reporting tools to centralize reporting and provide the latest updates and best practices for technicians. This prevents teams from using old and obsolete reporting standards, reducing risk and enabling more accurate outcomes. 

Prevent accidents and injuries

There’s little room for performance issues or failure when handling medical equipment. Small issues can lead to catastrophic outcomes, including accidents, injuries, or worse. Digitizing medical reporting improves accuracy, which leads to fewer errors and vulnerabilities slipping into production. 

FLX Systems streamlines medical QA & QC reporting with Vizual Proof, a mobile video and e-file service that seamlessly adapts to virtually any reporting or inspection need. To learn more,
schedule a demo today.