All "Compliance" articles

• October 29, 2021

What are the Differences in the FDA Medical Device Classes?

If you're getting a replacement heart valve, you want to know the device going in your chest went through a different approval process than a pair of ...

• June 08, 2021

How to Ensure Your Quality Management System Processes and Procedures are Compliant in 2021?

In highly regulated industries like life sciences, you have to make sure every i is dotted, and every t is crossed. The US FDA and other regulatory ...

• May 11, 2021

Biopharma Quality Management: 5 Steps to Guarantee Regulatory Compliance

In recent years, the biopharmaceutical industry has experienced an onslaught of regulatory changes. When you consider the total volume of regulatory ...

• May 04, 2021

How to Prepare for and Pass an Audit – and What to Do Next

Sooner or later, every life sciences, biotech, pharma, or medical device manufacturer will face an audit. Whether that’s a pre-approval inspection, a ...

• February 01, 2021

Qualio is Officially ISO 9001 Certified!

At Qualio, we’re all about helping life sciences, biotech, pharma, and medical device companies get products to market faster with our robust ...

• November 10, 2020

Does an FDA Class 1 Medical Device List Exist?

Understanding where your product falls in FDA classifications can help medical device manufacturers plan for regulatory compliance. If you can find a ...

• October 13, 2020

5 Major IEC 62304 Compliance Mistakes Medical Software Manufacturers Make

The international standard IEC 62304 is a standard that specifies life cycle requirements for the development of medical software. This standard is ...

• July 14, 2020

A Printable 21 CFR Part 11 Compliance Checklist to Follow Step-by-Step

For life sciences companies, 21 CFR Part 11 compliance has always been a challenge. It requires irrefutable evidence that your organization is ...

• March 12, 2020

Quality Management Initiative for Coronavirus and COVID-19

Quality Management Initiative for coronavirus and COVID-19 Starting today, we are offering our cloud Quality Management System (QMS) software and ...

Medical Devices

• February 13, 2020

14 Medical Device Quality Management System Requirements for Regulatory Compliance

Every day, three medical device quality managers open a piece of mail they will never forget. And these letters aren’t unforgettable in a good way. ...

Medical Devices

• February 06, 2020

Medical Device Quality Assurance and Regulatory Compliance in 2020: What You Should Know

Maintaining an edge means staying ahead of the competition and regulatory bodies when it comes to medical device quality assurance and regulatory ...

• January 07, 2020

Medical Device Compliance Consulting: 11 Questions to Ask Before Hiring

The FDA will send out three 483 observation letters today — will one of them be going to you? The process you have to go through to bring a medical ...

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