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EU MDR Article 61 Clinical Evaluation
The European Union (EU) Medical Device Regulation 2017/745 (EU MDR) aims to ensure a high level of...
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Regulatory Challenges for Novel Implantable Devices under EU MDR
In the European Union (EU), the Medical Device Regulation (EU MDR) has replaced the Medical Device Directive...
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Applying for Grants to Secure Funding
Preparing and applying for scientific grants can be laborious, time consuming, and laden with hurdles. This is...
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Navigating Biocompatibility: An Introduction to ISO 10993 Series of Standards
Medical device manufacturers should always refer to ISO 10993 Series of Standards in addition to region-specific regulatory...
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3 Steps to MDR/IVDR Compliant Systematic Literature Review
A systematic literature review is a method to collect, identify, and synthesize literature as objectively as possible...
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FDA’s New Guidance on Nitrosamine and Nitrosamine- Drug Substance Related Impurities and Recommended Acceptable Intake Limits
The FDA has recently published a Recommended Acceptable Limit guidance document for nitrosamine impurities in drug products....
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Creating a Conference Presentation: All You Need is an Hourglass
Creating an easy to follow, interesting, conference presentation is always the goal of conference attendees, but quite...
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Scientific writers and clinical evaluation reports (CERs)
Scientific writers can help you with your clinical evaluation needs. Clinical evaluation is an ongoing requirement for...
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Creating a Robust Clinical Evaluation Plan (CEP)
A clinical evaluation plan (CEP) may be necessary for your device. A medical device manufacturer that sells...
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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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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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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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