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2022 Guide: Software as a Medical Device (SaMD)

2022 Guide: Software as a Medical Device (SaMD)

What is software as a medical device? Software as a medical device, or SaMD is software that is intended for one or more medical purposes. This software performs those purposes without being part of a hardware medical device.  SaMD devices also need to meet the...

Design Controls Best Practices for Medical Device Companies

Design Controls Best Practices for Medical Device Companies

Ensuring regulatory compliance and fostering trust in products are paramount for medical device manufacturers. The FDA, European Competent Authority, and Health Canada closely oversee design, development, and manufacturing for patient safety and efficacy....

The Power of Trend Analysis in Drug Development with eQMS Platforms

The Power of Trend Analysis in Drug Development with eQMS Platforms

There is an intrinsic value of identifying trends in data for medtech manufacturers. Yes, the prospect of avoiding scrutiny from federal auditors is a tangible benefit. However, the true motivation for proactive medical device trend analysis lies in its power to...

The Tools For ISO 14971 Compliance for Medical Device Manufacturers

The Tools For ISO 14971 Compliance for Medical Device Manufacturers

The journey from concept to market-ready medical device is no easy feat. The regulatory economy, development and legislation is intricate. Understandably, compliance with standards is non-negotiable to ensure the safety and efficacy of medical devices. One such...