Cleanrooms are specialized and controlled environments vital for the manufacturing and packaging of medical devices. They are designed to reduce airborne particles, microbes, and other contaminants that could compromise device quality, efficacy, and safety. This...
Proper sterilization of medical devices is a necessity to reduce chances of infection caused by these devices. In this blog, we have discussed ETO sterilization for medical devices, which is a commonly used medical device sterilization method. What is medical device...
Medical device product recalls are part of regulatory oversight for ensuring the best quality devices are available in the market. Getting notified by regulatory authorities for product recall will tarnish the medical device manufacturer’s image. Hence, we have...
Medical devices should be properly labelled so that they are used as intended. This increases safety and reduces risk. Correct labeling of medical devices empowers healthcare professionals and patients to make informed decisions. Mistakes in medical device...
Risk management in medical device production is a systematic, dynamic, continuous, and multifaceted process. In this highly competitive medical device landscape, implementing risk management strategies is not only about compliance but also a necessity. Manufacturers...
The ISO 13485 guidelines provide a structured framework for establishing a quality management system that meets global standards. A properly designed and implemented QMS will ensure every step in the medical device production process is controlled and monitored. An...