Services for Medical Devices

To support its MedTech clients, YDL offers a wide range of regulatory services covering with National Competent Authorities, Ministries of Health and Notified Bodies within all major markets worldwide:

  • Post-market meeting to review and discuss strategies

  • Review and approval of all element of Submission data including the following:

  • Quality management systems (ISO13485) and GMPxx

  • Submissions/registration management

  • Follow-up meeting to discuss and resolve Q & A from submissions and registrations

  • Adverse events monitoring and reviews including devices undergoing clinical investigation

  • Review and management of product recalls

Our partner has worked in the MedTech industry for almost 20 years and have during this period supported numerous projects in the Medical Device industry, including medical device combination products for both Pharmaceutical and Biotech sectors.

 

To learn more, please contact us