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28 July |
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CE Mark for Medical Devices: Stay Ahead
The CE mark is of utmost importance in the European market, and understanding its intricacies is crucial for success. In this fast-paced and highly regulated industry, keeping up with the latest requi...
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Offering |
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27 July |
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Unraveling the relationship between EN ISO 149711 and GSPR of Regulation
The interrelationship between EN ISO 14971:2019/A11:2021 and the General Safety and Performance Requirements of Regulation holds great significance for device manufacturers in the EU. Collaborating wi...
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Offering |
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17 July |
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EUDAMED - European Database on Medical Devices
However, the new medical devices regulations (EU MDR) contain important improvements including a much larger EUDAMED database. The new EUDAMED will be multipurpose. It will function as a registration ...
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Offering |
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15 July |
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Clinical Development Plan
A clinical development plan is a subpart of a clinical evaluation plan which aims at the devices which are going for clinical evaluation or the devices undergoing clinical investigations in the future...
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Offering |
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22 June |
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European Medical Device Regulations
It has been said that European Medical Device Regulations is the most significant change to the regulatory framework in the medical device industry since CE Marking was introduced in 1993. Get detaile...
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Offering |
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20 June |
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Overall Residual Risk - How to Evaluate it ?
The risk management standard ISO 14971:2019 is the Holy Bible for medical device risk management. As elegant as it has been presented on its own, one could consider it as ISO’s tip of the hat to ack...
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14 June |
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Regulatory Compliance Solution CE for In Vitro Diagnostic Device
Get the EUDAMED registration done for IVD based on the regulations of EU 2017/746. We assist you get the CE for In-vitro Diagnostic Device CE Marking Service covering General IVDs, Self-testing IVDs a...
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Offering |
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13 June |
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Design History File for Medical Devices
Get your Design History File planned and approval for your medical devices in Vietnam, Malaysia, Hong Kong and Thailand. Get complete assistance in creating DHF as per the requirements of ISO 13485:20...
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Offering |
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05 June |
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Prepare perfect Technical File for UKCA Mark
Our consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The content of the Technical File for UKCA Mark is similar to that of ...
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Offering |
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29 May |
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Responsibilities of a UK Responsible Person in UK
We help you find the valid UK Responsible Person who is legally placed in UK market and help you getting UKCA mark. Definition of UK responsible person as per UK MDR 2019 is “ a person established i...
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Offering |