ISO 13485 vs ISO 9001: Key Differences

ISO 13485 and ISO 9001 are both quality management system (QMS) standards, but they serve distinct purposes within different industries.  While ISO 9001 provides a generic framework for quality management, ISO 13485 is specifically tailored to the medical device sector. Both standards share fundamental principles centered on customer satisfaction, process-based approaches, and continual improvement. Organizations...

Raising the Bar in Medical Device Compliance with Dot Compliance 

Welcome to the realm of regulatory excellence! In the intricate landscape of medical device manufacturing, regulatory compliance is not just a checkbox—it’s a commitment to ensuring the highest quality and safety standards. At Dot Compliance, we understand the pivotal role of compliance, especially with the stringent requirements outlined in 21 CFR Part 820. Navigating the...

Navigating FDA Compliance: A Guide to 21 CFR Part 210 and Part 211

In the pharmaceutical industry, ensuring the safety and quality of drugs is paramount. Manufacturers must adhere to stringent regulations set forth by the U.S. Food and Drug Administration (FDA) to meet the Current Good Manufacturing Practice (cGMP) standards.  For companies in the manufacturing, processing, packing, or holding of drugs, compliance with 21 CFR Part 210...

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.