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Data collection and management designed for MedTech clinical trials.

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Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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Get the latest updates and best practices in the MedTech industry from our blog. Join 200,000+ other MedTech professionals outperforming their peers.
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Chris Rush
April 12, 2024

Ultimate Guide to Clinical Data Management in MedTech

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Establishing a QMS

FDA Publishes Final Rule on QMSR

Etienne Nichols
February 2, 2024
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Establishing a QMS

Guide to Managing Your Medical Device on the Market and Scaling Manufacturing

Laura Maher
January 3, 2024
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Product Development

Why Training Compliance Matters for Pre-Market MedTech Companies

Etienne Nichols
July 31, 2022
Medical device companies in the pre-market stage tend to put training compliance on the backburner. It’s not that there aren’t directions for achieving compliance—ISO 13485... Read More
Product Development

3 Common Problems with Design Controls (and the Solutions)

Etienne Nichols
July 29, 2022
The first time you looked at 21 CFR Part 820.30—FDA’s regulations for design control—you probably thought, “Is that it?” Read More
Product Development

Examining FDA’s Refusal to Accept (RTA) Policy and Guidance

Nick Tippmann
July 27, 2022
After three “Refusals To Accept” Guidance Documents from the FDA, why are there still so many submission issues? Who’s to blame? Learn from other people’s mistakes. Read More
Product Development

Downstream Effects of Inadequate Complaint Handling

Etienne Nichols
July 24, 2022
Getting a product to market is the number one goal of any MedTech startup. But the job isn’t over once that product is on the market—it’s just the beginning. Read More
Product Development

What are the Distributor Requirements under EU MDR and IVDR?

Etienne Nichols
July 22, 2022
If you read the European Medical Device Regulation (EU MDR) and the European In Vitro Diagnostic Regulation (EU IVDR), you’ll notice that both regulations use the term... Read More
Product Development

Guerilla Tactics for Quality Leadership

Nick Tippmann
July 20, 2022
What are guerilla tactics for quality leadership? How do you implement a lean quality management system (QMS) and put requirements in place that are truly required -... Read More
Product Development

3 Tips for Managing Your Medical Device Design History File

Tom Rish
July 15, 2022
Your design history file (DHF) is one of the most critical components of your QMS. That’s because the DHF should contain all the product development documentation for a... Read More
Product Development

Preventing the Death of Medical Device Sales

Nick Tippmann
July 13, 2022
The medical device sales industry is slow to change. It’s behind on how hospitals and physicians adopt and adapt to buying, sales strategies are out of date, and increased... Read More
Product Development

5 Signs Your MedTech Startup is Ready for the Next Round of Funding

Etienne Nichols
July 10, 2022
Medical device startups are one of the greatest sources of inspiration in the MedTech industry. Read More

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