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Product Development

Computer Systems Validation: How To Avoid FDA Warning Letters C.F.R. 820.70(i)

January 27, 2023
Computer systems validation (CSV) is a standard regulatory exercise Med Device companies are required to complete. This is not new news.  Read More
Product Development

How to Collect PMCF Data for Lower-Class Medical Devices and WETs

January 27, 2023
Post-Market Clinical Follow-up (PMCF) is necessary for maintaining medical device regulatory compliance, and with the EU MDR, clinicians increasingly need to collect PMCF... Read More
MedTech Lifecycle Excellence

Essentials of Sterilization for Med Device Professionals

January 25, 2023
What tools do sterilization engineers need the most? What’s the difference between sterilization modalities? Those are some of the points that our guest will be... Read More
MedTech Lifecycle Excellence

UDI: 101

January 20, 2023
What is UDI? Why is it important, and what does the implementation of UDI look like? If you don’t know, you probably should start learning, and in today’s episode,... Read More
Product Development

How to Plan a Clinical Data Management Setup for EDC Systems

January 20, 2023
When it comes to setting up forms and questionnaires for EDC systems, we’ve noticed a trend. Most are keen to get their study started but have not considered what it takes to... Read More
MedTech Lifecycle Excellence

Quality Myths and Lessons Learned

January 18, 2023
What words cause the most problems in MedTech, and what situations should you be ready to handle when you work in Quality? Today’s guest wrote about these issues in... Read More
Establishing a QMS

Greenlight Guru Announces Partnership with Comply Guru

January 17, 2023
Partnership will allow the medical device industry’s leading software platform to provide a wider range of courses in a variety of on-demand and blended learning formats.   Read More
Product Development

3 Types of QMS Audits (Plus 3 Tips to Prepare for Them)

January 15, 2023
The purpose of a QMS audit is to ensure your company has established the appropriate processes and procedures within your quality management system (QMS), and that those... Read More
MedTech Lifecycle Excellence

Determining User Needs for Your Medical Device

January 13, 2023
What is a user need, and when should you start working on them? How can you figure out what the user truly needs – and by the way, do you know who the user is? These... Read More

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