All "Compliance" articles

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 ...

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 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 ...

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 ...

5 Common Medical Device Regulatory Compliance Problems Faced in 2020

Is the thought of achieving and maintaining regulatory compliance stressing you out? It's a good thing that our friends in the pharmaceutical ...

5 Medical Device Compliance Problems That Can Permanently Damage Life Sciences Companies

Medical devices have been responsible for more than 80,000 deaths since 2008, according to STAT. The total number of complications resulting from ...

ISO Compliance: The What, Why, and How for Life Sciences Companies

As a life sciences company, you play a major role in the overall global economy. Your products can be quite literally life-changing for the people ...

Why Did Medical Device FDA 483 Observations Drop 6.2% Last Year?

In 2018, the FDA issued 124 fewer 483 observation letters to medical device companies than they did the previous year. In 2017, there were a total of ...

How to Enable Quality Controls in Life Sciences Marketing

Most life sciences companies are aware of the dangers of marketing noncompliance on their products. In recent years, major pharmaceutical ...

Quality vs. Compliance: These 5 Questions Will Determine Your Focus

What is Quality v Compliance? Have you ever recommended a restaurant based on their lack of health violations? Listen to the audio version of this ...

What You Need To Know About Part 11 Compliant Document Management Systems? (Top 4 Providers)

If your company is in a highly regulated industry—including pharma, medical devices, biotech, biologics, or CROs—you have to decide how to approach ...

Understanding the Growing Need for Product Compliance Software

The life sciences industry is under an incredible amount of pressure from regulatory authorities, patients, and market conditions. Regulatory ...
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