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Product Development

Nonconformance (NC) and CAPA: When Should You Use Each Process?

December 2, 2022
Your nonconformance (NC) and Corrective Action and Preventive Action (CAPA) processes are two critical elements within your quality management system. Read More
Product Development

What Device Makers Need To Know About Design Verification and Validation

November 21, 2022
Design verification and validation are two essential steps in medical device product development. It’s easy to confuse the two, but there’s a simple way to remember them: Read More
Product Development

Understanding Root Cause Analysis in the CAPA Process

November 20, 2022
Corrective and preventive actions (CAPA) is a cornerstone to ensuring the quality of medical device manufacturing. Perhaps that’s the reason why improper CAPA procedures are... Read More
Product Development

How Does the EU GDPR Impact Medical Device Clinical Trials?

November 17, 2022
Mid 2018, most inboxes were flooded with updates on new privacy policies and data processing agreements. All credit went to the newly applicable European Union (EU) General... Read More
Establishing a QMS

CAPA Process: Step-by-Step Instructions [+ Free Infographic]

November 15, 2022
The CAPA process is a frequent topic of discussion here at Greenlight Guru, mainly because it’s still such a big issue for medical device companies. Year after year, CAPA... Read More
Establishing a QMS

Ultimate Guide to IVDR for In Vitro Diagnostic Medical Device Companies

November 13, 2022
The global medical device industry is a space where forward thinking meets problem solving, all for the same purpose: to improve the quality of life. However, if you’re going... Read More
Product Development

8 Tips Before Calculating Sample Size in Medical Device Clinical Studies

November 11, 2022
Sample size calculation is important, not only because of industry regulations, but also because of ethical considerations. In this blog, I am going to highlight the... Read More
Product Development

MDCG Guidance Documents Overview on Clinical Investigations and Evaluations

November 3, 2022
The EU Medical Device Coordination Group (MDCG) has provided a series of guidance documents for manufacturers to use on their path to MDR compliance. In April 2020, the... Read More
Product Development

3 Common Misconceptions About Medical Device Labeling

October 21, 2022
When you first start designing and developing a new medical device, you’re investing a lot of time, whether that’s in studying design controls, design inputs and outputs, or... Read More

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