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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

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
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
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
Product Development

5 Tips for Running Effective Internal Quality Audits

January 6, 2023
How did your last internal quality audit go? Internal audits can be a bit of a scramble for some medical device companies.  Read More
Product Development

7 Key Pitfalls To Avoid In MedTech Clinical Data Collection

January 6, 2023
With 10 years of experience in the MedTech field, clinical data experts and co-founders of SMART-TRIAL by Greenlight Guru, Páll Jóhannesson and Jon Bergsteinsson have noticed... Read More
Establishing a QMS

Tips for Structuring Your Internal Audit Program (and Mistakes to Avoid)

January 1, 2023
After a refreshing holiday break, there’s one question you need to ask yourself as you head into the new year: Do we have a plan in place for internal auditing this year? Read More

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