Medical Device Manufacturing Archives

What to Know about IEC 62304 and Why It’s Important for SaMD

March 7th, 2024

10 min read

Digital transformation has ignited a change in the medical device industry, one that leverages technology to create life-saving devices. Not just as a component of a medical device but as the medical device itself. This clear distinction is what’s known as Software as a Medical Device (SaMD). The International Medical Device Regulators Forum (IMDRF) defines...

Revolutionizing Complaint Management in Medical Device with AI-Integrated Quality Management Software

Artificial Intelligence

January 30th, 2024

10 min read

Introduction: In the fast-evolving landscape of the medical device industry, ensuring the highest quality standards is paramount. Complaint management plays a crucial role in identifying, addressing, and preventing issues related to product quality and patient safety. As technology continues to advance, the integration of artificial intelligence (AI) into quality management software solutions has emerged as...

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QMS 101: Medical Device Validation

Best Practices

October 10th, 2022

10 min read

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

Best Practices

September 11th, 2022

10 min read

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

Medical Device Manufacturing

August 25th, 2022

4 min read

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

Best Practices

June 16th, 2022

10 min read

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

Medical Device Manufacturing

April 12th, 2022

5 min read

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

Medical Device Manufacturing

March 25th, 2022

8 min read

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.