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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Accelerate development with integrated design control and risk software.

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Design Controls Risk Management Risk Intelligence

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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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Post-Market Surveillance

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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Post-Market Surveillance

The Medical Device Practical Guide to PMCF Requirements under EU MDR

Jon Bergsteinsson
October 3, 2022
The European Medical Device Regulation (EU MDR) deadlines are closing in for re-certification and/or introduction of new products. Read More
Post-Market Surveillance

10 Tips for Selecting the Right EDC Software for Clinical Investigations

Páll Jóhannesson
September 29, 2022
Using Electronic Data Capture (EDC) software can save you time and money in the data collection process for your medical device clinical investigation - but how do you... Read More
Product Development

7 Common 510(k) Mistakes and How to Avoid Them

Etienne Nichols
September 28, 2022
The 510(k) is the workhorse of regulatory submissions to the FDA from the medical device industry in the United States. However, 510(k)s continue to be the source of... Read More
Post-Market Surveillance

Compliant Adverse Event Reporting in Clinical Studies under the EU MDR

Páll Jóhannesson
September 22, 2022
Under the EU MDR, both pre- and post-market clinical investigations shall follow the latest requirements for Good Clinical Practice (ISO 14155:2020). Recording and reporting... Read More
Post-Market Surveillance

eCRF Template for Clinical Investigations and PMCF Studies

Jon Bergsteinsson
September 15, 2022
The key to an effective Electronic Data Capture (EDC) system setup is proper planning. If electronic Case Report Forms (eCRF) are not prepared well before setup, you can risk... Read More
Product Development

Building Your Regulatory Strategy for Commercialization

Etienne Nichols
September 14, 2022
What should early-stage entrepreneurs and medtech companies consider with commercialization in relation to how regulatory strategy affects business roadmap, pitfalls... Read More
Product Development

Packaging Validation Best Practices

Etienne Nichols
September 7, 2022
The packaging of medical devices, especially sterilized products, is often overlooked and does not make news headlines until it’s done wrong. How can packaging and labeling... Read More
Post-Market Surveillance

The Practical Guide to Post-Market Clinical Follow-up EU MDR Compliance

Jon Bergsteinsson
September 4, 2022
Everything a Medical Device Manufacturer Needs to Know About Post-Market Clinical Follow-up Read More
Post-Market Surveillance

How to Design a Successful Post-Market Clinical Follow-Up (PMCF) Survey

Jon Bergsteinsson
September 1, 2022
PMCF Surveys are one of the tools medical device manufacturers can use to collect data for Post-Market Clinical Follow-Up (PMCF). But a PMCF survey under the MDR is not like... Read More

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