Steps to Consider When Dealing With 483 FDA and Warning Letters

The FDA sends an FDA Form 483 Observation, also known as a “inspectional observation” or “Form 483” to draw attention to any potential legal infractions discovered during a routine inspection. These are issued after a 483 FDA inspection. An FDA Form 483 Observation may concern the company’s building, tools, controls, procedures, goods, personnel conduct, or...

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 Ultimate Guide to ISO 9001 QMS

The Quality Management System (QMS) doesn’t have any independent standards. It depends on other accepted standards for its definition, application, and actual execution such as ISO 9001. It is the obligation of the firm to implement the pertinent standards, which vary depending on a variety of elements, such as location, product type, and target market....

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...

ISO 17025 Checklist (with XLS Download)

One of the most significant limiting factors in the quality of a pharmaceutical, medical device, or other life sciences product is the quality of the laboratory where development and testing occurs. The way to ensure that your products meet the highest standards of quality and consistency — and convey your commitment to meeting these standards to customers and other parties — is to obtain ISO 17025 accreditation.

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.