Common Manufacturing Practices in Medical Device Industry

Alex D'Souza, Medical Tech Outlook | Thursday, April 29, 2021

Maintaining compliance with Current Good Manufacturing Practices is essential for medical device manufacturers who prioritize safety, quality, and product integrity. 

FREMONT, CA

The medical devices sector is an integral part of the healthcare system, helping the production of medical devices and the advancement of medical technologies that can aid in the diagnosis and treatment of various illnesses.

The medical devices industry encompasses a wide range of products, from everyday things like surgical masks to high-tech imaging equipment. This category is defined by the Federal Food, Drug, and Cosmetics Act as any substance that is not consumed or metabolized by the body and is utilized for the "diagnosis of disease or other conditions, or in the cure, reduction, treatment, or prevention of disease."

How The Medical Devices Industry Is Handling the Technological Evolution 

The medical device industry has advanced rapidly in accordance with today's technological evolution. The medical device industry has also started to look at virtual reality therapy and transcranial magnetic stimulation to address drug addiction in the future.

Medical researchers have also developed a "microgel" coating for medical implant devices to identify bacteria approaching the implants. This invention is thought to minimize the number of patients that become infected after surgery. If effective, the microgel may aid healthcare systems in reducing complications and the use of antibiotics to treat infections.

The Importance of Good Manufacturing Practices for Medical Device Industry

The CGMP system is critical to the manufacturing process since it guarantees a certain degree of consistency, security, purity, and strength in any items that are made available to the public. Following these guidelines will help a company reduce product recalls, adverse effects, and defects, all of which can lead to expensive liability litigation in the future.

What Are the Norms of Good Manufacturing Practices?

Quality

This move includes setting up a framework that ensures each pharmaceutical product has a unique identity, power, purity, and other quality characteristics that guarantee the necessary standards of security and efficacy.

Quality by Design and Product Development

This idea entails designing and creating a product, and the related manufacturing processes, to determine whether it satisfies specified a predetermined quality standard at the end of the manufacturing process.

Quality Risk Assessment

This definition may include the setting of requirements and processing methods for drug manufacturing, evaluating and minimizing the risks of modifying a process, and determining the scope of inconsistency investigations and corrective measures, depending on the product.