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Can the safe history of clinical use be used as justification for biocompatibility of a medical device?
Can the safe history of clinical use (no complaints registered in PMS) be used as justification not...
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What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a detailed summary of the evaluation of information pertaining to clinical...
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Quality System Remediation and Root Cause Analysis
Successful quality system remediation relies on understanding why problems arose, generally referred to as “root cause analysis.” ...
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Remediation, Regulatory Compliance, and Company Culture
FDA Warning Letters are devastating – a Quality Manager’s worst nightmare – a major shock to any...
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Exploring the EU MDR’s Impact on ‘Legacy’ Medical Devices
Devices already legally on the market under the European Union’s (EU) Medical Devices Directive (MDD) or the...
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FDA Remediation Services
Have you been issued an FDA Form 483 or Warning Letter? We can relate to how stressful...
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European Medical Device Regulation (MDR)
The European Medical Device Regulation (MDR) is a new set of regulations that will become effective May...
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Claiming Equivalency Under EU Medical Device Regulation
Compared to the Medical Device Directive (MDD) 93/42/EEC, the Medical Device Regulation (MDR) No. 2017/745 introduces a...
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EU Medical Device Classification
Understanding the classification of your medical device before CE marking is a critical step as it affects...
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Clinical Evaluation Report (CER) Literature Searching
To maintain compliance with heightened requirements under the Medical Device Directive (i.e., recent Notified Body implementation of...
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Regulatory research on IDE exemptions: A case study in persistence (part 2)
In our previous blog post, we described our preliminary regulatory research study on whether our client’s electronic...
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Regulatory research on IDE exemptions: A case study in persistence (part 1)
A client presented us with a simple question – Do we need to submit an Investigational Device...
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