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Establishing a QMS

Should ISO 15189 Certification Matter to Medical Device Companies?

October 14, 2022
For medical device manufacturers, a medical laboratory can play a huge role in the success of a product. This is where many types of testing can occur. Whether it’s for... Read More
Product Development

Quality Assurance vs. Quality Control in the Medical Device Industry

October 10, 2022
Imagine that your medical device malfunctioned during patient use. Do you know whether quality assurance or quality control is responsible? When working through remediation... Read More
Product Development

The Ultimate Guide To Design Controls For Medical Device Companies

October 10, 2022
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Product Development

Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference?

October 7, 2022
The medical device industry has a lot of acronyms.  Read More
Product Development

Generate MDR Compliant Clinical Data with Investigator-Initiated Studies

October 6, 2022
The number of Investigator-Initiated Studies (IIS’s) conducted globally is on the rise. Independent patient-focused clinical studies led by physicians play an integral role... Read More
Establishing a QMS

Ultimate List of ISO Standards for Medical Devices

October 5, 2022
The International Standardization Organization (ISO) is an independent, non-governmental organization that has created thousands of international standards for numerous... Read More
Establishing a QMS

21 CFR Part 11: A Complete Guide

October 5, 2022
Medical device companies that wish to sell their devices in the US and EU must implement a quality management system that meets the requirements of 21 CFR Part 820 and ISO... Read More
Establishing a QMS

Ultimate Guide to ISO 13485 for Medical Devices QMS

October 3, 2022
  Table of Contents What is ISO 13485 Evolution of a Quality Management System Requirements for ISO 13485 Certification ISO 13485... Read More
Product Development

ISO 14971 Risk Management for Medical Devices: The Definitive Guide

October 3, 2022
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