All "Compliance" articles

• October 29, 2024

What you should know about the CE mark

• October 21, 2024

What you should know about UKCA marking

If your medical device business plans to introduce its product to the $25bn UK market, you'll need to incorporate UKCA marking into your quality and ...

• July 09, 2024

A guide to writing corrective and preventive action (CAPA) reports

• June 14, 2024

What is Corrective Action Preventive Action (CAPA)?

• June 03, 2024

How to build a complaint management system

What’s more dreadful than receiving a customer complaint? Being asked by a regulatory auditor how you handled the complaint and if you effectively ...

• May 30, 2024

CDSCO registration: how to bring your medical device to India

• May 29, 2024

The ultimate guide to change control for life sciences companies

• May 08, 2024

The EU AI Act: what to expect

Medical Devices

• March 20, 2024

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. ...

• February 17, 2023

5 notorious compliance issues in the pharmaceutical industry

Does the prospect of getting an FDA 483 letter keep you up at night? You’re certainly not alone. Compliance pressures in pharma have never been ...

• October 20, 2022

A step-by-step guide to internal quality audits

Gearing up for a quality audit is no small feat. Whether it’s your organization’s first time being audited or the 100th, there’s always room for ...

• September 22, 2022

What are the types of quality audits?

Audits. If you work in life sciences, you know that quality audits are a part of creating life changing products. Though all quality audits aim to ...

• August 30, 2022

21 CFR Part 11: Compliance in the supply chain [Checklist]

21 CFR Part 11 applies to any official quality or manufacturing records pertaining to the design, development, or manufacture of a drug or device ...

• August 09, 2022

21 CFR Part 11: A guide for clinical trial compliance

When conducting or managing any part of a clinical trial, from pre-study through close-out, compliance with 21 CFR Part 11 is always required. The ...

• 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 ...

• 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 ...

Medical Devices

• November 19, 2019

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 ...

• October 15, 2019

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 ...

• August 27, 2019

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 ...

• April 09, 2019

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 ...

• March 14, 2019

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 ...

• December 18, 2018

Essential Tools to Achieve Compliance in the Pharmaceutical Industry

Data integrity was a crucial trend in warning letters issued by the FDA last year, along with a significant increase in international inspections. ...

• September 28, 2016

5 Ways that a QMS Improves ISO 9001 Management

A Quality Roadmap for Therapeutics Developers, Medical Device Companies and Contract Manufacturers

• November 18, 2014

If it’s not documented, it didn’t happen

Document Control

• April 28, 2014

Failure to Comply - Document Control in a Regulated Industry

It is not possible to overstate the importance of effective document control in a highly regulated industry such as medical devices. Those of you ...