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.