QMS 101: Medical Device Validation

The process of ensuring medical equipment will operate safely and correctly is known as medical device validation. Regional regulatory organizations and worldwide standards, which frequently overlap when it comes to product needs, determine the requirements for validation and verification. Each manufacturer employee that works on creating medical equipment must complete the necessary training. Quality assurance...

The Ultimate Guide to 21 CFR Part 11 QMS

FDA 21 CFR Part 11 is a rule that specifies how businesses that are subject to FDA regulation, such as those in the medical device, pharmaceutical, and other industries, should manage their electronic records and electronic signatures. Organizations must abide by several rules and different sets of criteria that are specific to the life science...

The Essential Guide to ISO 13485 for Medical Device

ISO 13485 outlines the specifications for quality management systems (QMS) for medical devices. Both internal audits and external auditors (typically notified bodies) will test the validity of the quality management system. A medical device can be as simple as a first aid bandage or as complex as a pacemaker on which a patient’s life is...

Quality Management System (QMS) for Medical Device

In this post, we will take a deep dive into the medical device quality management system, look at the principal regulations governing the QMS, the difference between a QMS and an eQMS, and how a robust eQMS can solve the regulatory quagmire for medical device manufacturers.

A Guide to Medical Device Labeling Requirements

As an indispensable part of the medical device that ultimately ends up on the market, labeling is subject to FDA quality assurance requirements. These relate to the materials, operations, and controls of your labeling process, as well as the manner of application, inclusion in packaging, and other factors. To produce compliant labels, manufacturers have to manage, track, and update a significant amount of data.

The Essential Guide to ISO 14971

The International Organization for Standardization created ISO 14971 to assist medtech manufacturers in developing processes for evaluating, monitoring and controlling the risk that their products could cause harm to patients, operators, or other individuals. ISO 14971:2019 is the third and most recent edition of the standard.

The Essentials of Software as a Medical Device (SaMD)

The digital revolution and IoMT (Internet of Medical Things) has transformed the healthcare landscape. Software and connected devices are now being used to power disruptive medical technologies and solutions. Bioinformatics, point-of-care diagnostics, and 3D printing are just a few of the exponential medicine breakthroughs enabled. Software is changing how healthcare professionals act and react, how they interact with their patients, and patients' abilities to take charge and manage their health like never before.

Future Trends and Regulatory Challenges in Medical Device

Medical device manufacturers continuously try to streamline operations, improve quality, and reduce costs while struggling with global supply chain disruptions and changing regulatory requirements.