Our Approach to Technical Documentation in International Markets 

MCRA can assist with development, writing and reviewing of your technical documentation for submission to the specified regulatory body through the use of MCRA's subject matter expertise. The MCRA team has the ability to train in your company's processes and develop all documentation per internal procedures and templates, or MCRA services can include document building based on MCRA-developed templates. MCRA Product Registration services include:

  • Gap Analysis:

MCRA can perform a thorough review of current documentation to identify gaps in the submission documentation and data

  • Technical Documentation Development:

MCRA can compile compliant technical documentation and customize based on desired market(s) and company processes

  • Clinical Evaluation Report (CER) Development:

MCRA can assist with the strategic planning and development of device CERs for a number of device technologies and all device classifications (for more info about CERs click here)

  • Essential Requirements:

MCRA can assist with, and create a checklist that demonstrates your device meets all applicable Essential Requirements/Principles

  • Maintenance:

MCRA can assist with maintaining the technical documentation including regular updates, design changes  safety feedback, and recertification


Contact a Regulatory Affairs Expert