The medical device industry is responsible for the design and manufacturing of a wide range of products used to diagnose and treat illnesses and improve health in patients. A responsible manufacturer in the medical device industry bring in billions of dollars in revenue every year.

Because medical devices are essential tools for healthcare, and because these devices have direct impacts on public health and quality of life, their safety is imperative. To create desirable outcomes for all parties and prevent device recalls, companies must follow relevant medical device manufacturing standards. These standards help ensure that a manufacturing or design process can consistently produce the quality required to serve patients and healthcare professionals.

YOUR CHALLENGES

In order for your products to be placed on the European market, they must meet the requirements of the relevant product directives. We help you understand and meet these directives to ensure your product completes the CE Marking process efficiently and successfully.

Today’s consumers want to know where their product comes from, how it was made and processed, and how its quality was preserved. As a Medical Device industry professional, you need to demonstrate

  • Good Manufacturing  Practices

  • Full Product traceability

  • Compliance to stringent regulations to meet complex requirements

  • Ensuring safety performance and efficacy of the product

HOW WE SUPPORT YOU

Through our team of experts, we provide, value-added services for various types of Medical Devices.

  • Product Safety Testing

  • CE mark Certification

LEARN IN DETAIL ABOUT OUR TESTING AND CERTIFICATION SERVICES

Medical Devices – CE Marking