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28 July
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...  Offering
27 July
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...  Offering
17 July
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 ...  Offering
15 July
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...  Offering
22 June
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...  Offering
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20 June
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...  Offering
14 June
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...  Offering
13 June
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...  Offering
05 June
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 ...  Offering
29 May
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...  Offering
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