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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
Product Development

IQ, OQ, PQ: A Quick Guide to Process Validation

January 20, 2023
IQ, OQ, and PQ are the abbreviations we use in the medical device industry for the three steps of process validation. Read More
Product Development

Understanding the 5 Phases of Medical Device Development

January 20, 2023
The purpose of any medical device is to benefit others and improve the quality of life. However, in order to keep patient and user risk at a minimum, authorities have... 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
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
Establishing a QMS

9 Steps to Creating a CAPA Audit Checklist

January 13, 2023
As you conduct internal audits, you may uncover items to address. If these issues are systemic in nature, then these issues are likely candidates for a more thorough... Read More
Product Development

The 3 C’s of the EU MDR: Changes, Challenges and Contributions

January 12, 2023
The new European Union Medical Device Regulation (EU MDR) comes with a steep path to compliance. But it also comes with a more effective path to achieving a common goal - 'A... Read More

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