All because of human ingenuity, technology has excelled in astonishing leaps and bounds. It comes to the point that almost every aspect of life is somewhat altered and even improved upon by technology. The same could be said for the medical field. 

Healthcare professionals, specifically those specializing in medical technology, are already well-acquainted with having technology influence the quality of life for the better due to its many benefits. These advantages include efficiency, automation, and accuracy. 

Manufacturing companies are expected to apply these benefits to their medical devices. However, the point where these companies may diverge is when compliance and quality are touched.

What Is A Medical Manufacturing Software

Medical Manufacturing Software is one of the types of software being integrated into the medical field by the Food and Drug Administration (FDA). This type is what you can consider as the ‘heart and soul’ of the manufacturing industry.

Many non-software professionals tend to confuse these types of software due to their influence in the medical field. Although, the key difference is the medical purpose they’re supposed to fulfill. While other types concentrate on the medical device itself, medical device manufacturing company RBC and similar manufacturers have this software to automate the process of creating medical devices.

Importance of Compliance and Quality

Safety is a must when discussing medical devices. However, assessing their safety always starts from its manufacturing company or more specifically, its medical manufacturing software. Since it has complete control over the hardware, evaluation is another responsibly of the software.

This evaluation adheres to the Quality Management System (QMS), which functions to follow the global standard manufacturers. Considering this ensures high-quality product as this system answers to their customers’ safety. Therefore, this builds the foundation for better repeat business transactions.

What To Consider To Balance Compliance and Quality

Although, artificial intelligence is already showing promising results in software development in non-medical fields. Thus, knowing how the medical manufacturing software measures compliance and quality are essential in case of emergencies, such as:

  • Forming new defects from updates.
  • Hiding defects under new updates.
  • Developing another problem elsewhere after fixing it.

Seeing how software can’t be developed without its personnel, here are the factors the medical manufacturing software takes into account.

1. Class of Medical Device

Before you can create a medical device, the first thing the software does is identify which class it falls under so it remains in line with the regulations the FDA laid out, and these classifications are labeled as follows:

  • Class I: These have general regulation controls, which makes them the less-risky category out of all three. Therefore, allowing them to be either exempted or not exempted from Premarket Approval (PMA). One example is a medical device that can measure your vitals without inflicting injury.
  • Class II: They also have the same quality as Class I which can be exempted or not exempted from PMA. However, in addition to its controls for general regulation, it includes special controls to adhere to specific compliance requirements for performance, labeling, testing, and post-market surveillance. An example of this would be blood transfusing devices.
  • Class III: will require PMA, unless there’s already a user-friendly predicate device in the market that acts as a substantial equivalent. Therefore, proving there’s no need for PMA. Be that as it may, it’s safer to apply for PMA to better your device’s path to market. For this type, defibrillators are the best example.

In the end, these classifications depend on the device’s medical purpose, such as the more risk it can cause the patient the higher its classification. However, if you merely relied on its intended use, you might be confused in identifying which is Class II or III. Thus, the FDA has a database where you can input the medical device’s production code and it will do the work of specifying it from 16 specialties.

2. Corrective And Preventive Action

In handling a medical device, always remember there’s a risk despite its controls. Although medical manufacturing software implements heavy regulations in line with FDA, that risk may never go away. Therefore, the Quality Management System (QMS) must establish Corrective and Preventive Action (CAPA) from within to function safely for the customer and the patient.

3. Verification Results

Conducting numerous tests to document the medical device’s performance is a common practice. However, that only applies to the hardware and not to its software. On top of recording the hardware’s performance, you must conduct various verification techniques to the software itself to check for anomalies. 

In addition, it’s highly recommended you record its original development process for future maintenance personnel to be familiar with its structure. Therefore, preventing any defects from developing out of new updates.

The Bottom-line

As technology continues to develop, so does its spread across different platforms. Just like the rest of these platforms, the medical field usually takes full advantage of it by improving its performance, especially in the medical manufacturing industry.  

As a result, the software now regulates what used to take hundreds of people to ensure each product conforms to quality standards. Hence, furthering the development of high-quality medical devices for customers.