Featured Articles

1. Keys To Managing Change Control Effectively In Medical Device Manufacturing 9/20/2024

   Learn why staying competitive means medical device manufacturers must respond to customer needs promptly and adapt swiftly to changes in the market

2. MasterControl Raises $150M Series A Funding Round From Sixth Street Growth At Valuation Of $1.3B 12/19/2022

   MasterControl, a leading provider of quality and manufacturing software solutions for the life sciences, announced its first ever funding, a $150 million Series A round led by Sixth Street Growth. MasterControl has grown profitably for nearly 30 years, and with this funding is valued at $1.3 billion. The proceeds will be used to accelerate the development of SaaS solutions serving the company’s global life sciences customers, which include Pfizer, Cochlear, Thermo Fisher Scientific and more than 1,100 others worldwide.

3. The Criticality Of Supplier Management And Keys To Improvement 10/4/2022

   Learn how to simplify and strengthen your supplier management program with quality assurance through supplier risk management, tools for enhancing supplier oversight, and more.

4. Digital Solutions For Combatting Counterfeit Med Devices And Pharmaceuticals 9/29/2022

   Learn how digital solutions and a modern ERP system can effectively combat counterfeit med devices and pharmaceuticals to improve patient safety and business performance.

5. FDA's Newest Medical Device Security Guidance 9/23/2022

   We take a closer look into how the industry will respond to an upcoming FDA guidance on cybersecurity in medical devices regarding quality system considerations and content of rremarket submissions.

6. 6 Essential Capabilities Of A Complete eDHR System 8/26/2022

   We share tips on how to implement an eDHR system that allows you to capture and leverage all the data needed to optimize production while ensuring compliance with FDA 21 CFR Part 820 requirements.

7. Clarifying Process Verification vs. Process Validation In Med Device 7/13/2022

   We answer frequently asked questions to provide background on the intent of the QSR and should shed light on the FDA's perspective of the verification vs. validation conundrum.

8. A Guide To Digitizing Med Device Manufacturing Operations 7/6/2022

   This guide explains what a truly connected, paperless environment looks like while using Manufacturing Excellence.

9. Top 5 Pitfalls You Should Know About Medical Device Quality System Auditing 6/24/2022

   Learn about the critical questions to ask while planning medical device audit management activities, as well as the five common problem areas with medical device quality system auditing. 

10. What CDMOs Should Know About Digitization 6/24/2022

    Explore how embracing digitization in manufacturing can help CMOs and CDMOs improve the efficiency of their operation and attract company partnerships.