#technicalfilesformedicaldevices

In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). To gain approval for a medical device technical file in Australia, manufacturers are required to create a Technical File or Technical Documentation, which contains detailed information about the design, manufacturing, and performance of the device. Consulting with regulatory experts or the TGA is advisable to ensure that your Technical File meets all necessary criteria.

Technical Files for medical devices in the UK are essential documents that contain comprehensive information about the design, manufacturing, and performance of a medical device. These files are a crucial part of the regulatory process and are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. It's important to note that the specific requirements for Technical Files can vary based on the classification of the medical device and any updates or changes in regulations. Consulting with our regulatory experts or agencies like the MHRA is advisable to ensure that your Technical File meets all necessary criteria.

Technical Files for medical devices in the UK are essential documents that contain comprehensive information about the design, manufacturing, and performance of a medical device. These files are a crucial part of the regulatory process and are submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Consulting with our regulatory experts or agencies like the MHRA is advisable to ensure that your Technical File meets all necessary criteria.

We help you to prepare Medical Device Technical File (MDR) as per the regulatory requirement of EU MDR 745/2017 and submit to notified body for review and approval of CE certification. Our regulatory consultants in Maven who are experienced in various fields of Medical Device Regulations are well versed in taking care of technical documentation like clinical evaluation, Benefit-Risk Analysis, validations, design and development files, shelf life stability study, usability engineering files, safety and biological evaluation, and chemical characteristics evaluation.