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Safety of medical devices

日期: 2020-06-09

EMTEK assists our clients from the beginning of the product development cycle to certification, working together with our clients throughout the cycle on risk management files (RMF), electrical safety, electromagnetic compatibility (EMC), testing and performance evaluation.

 

EMTEK’s medical device safety testing

 

Training services

EMTEK is well aware of the challenges facing medical device manufacturers and is committed to helping you solve them with professional advice and services. We have rich educational resources, can provide the latest standards of education and training for manufacturers. We will let you be aware of the standards, access requirements changes the soonest, so as to help you prepare in advance and get access to the global market even faster.

 

Development and design services

In the early design phase of a product, we will help you better understand how to design medical devices according to standard requirements, so as to ensure that your product will successfully get market access and costly repetitive designs can be avoided.

 

Technical documentation service for Medical Device Directive (MDD)

The MDD Directive requires manufacturers to provide complete technical documentation for medical devices and software products. Our engineers will provide support during the preparation of technical documentations, including inspection of technical documents and review of the entire document structure and details. This will save you enormous time and reduce product risks.

Risk management process design services

EMTEK has a solid expertise in risk management theory and tools. We can help you identify potential harms the product may cause to end users at all stages of the product life cycle. For each level of risk identified, EMTEK will objectively develop a solution to help you determine what steps to take to mitigate the risk.

 

Safety and performance testing services

IEC 60601-1 (The 3rd edition) : There is a greater emphasis on risk management in the 3rd edition, so there are many ways to verify a product’s compliance with requirements. EMTEK will walk you through the certification process in an interactive risk management approach.

 

List of test standards

 

Name of standard

Test standard

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance


Medical electrical equipment Part 1-1: General safety requirements and standard safety requirements for medical electrical systems


Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs


Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment


Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devicesusing blankets, pads and mattresses and intended for heating inmedical use


Medical electrical equipment Part 2-38: Particular requirements for the safety of electrically operated hospital beds


Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors


Medical electrical equipment - Part 2-51: Particular requirements for safety, including essential performance, of recording and analysing single channel and multichannel electrocardiographs


 


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