DHF & Tech-File Remediation
Design History Files and Tech Files are compilations of records which describe the design history of a finished device, including design review, verification, and validation. A well-established, formal, Design Control process will ensure that the DHF and Tech-Files contain all of the records required. As the medical device regulatory requirements change and as you update your Quality System, it is important to ensure that Design History Files and Tech-Files for legacy products are compliant to the new standards.
Benefits of using Swiss MPC
The right team for your Remediation
Our experts can help you perform any necessary activities to fulfill your remediation needs while working under your Quality System. We will do whatever it takes to make sure all documentation for your existing products is complete, accurate, robust, up to standard and ready for the next audit. Find out more about why our DHF and Tech-File Remediation Service is the right fit for you.
Swiss MPC offers DHF and Tech-File Remediation services to update all necessary documentation and maintain the compliance of your medical device throughout its lifecycle. Our team of experts will identify gaps in the existing technical documentation followed by the formulation or update of the documentation to comply with applicable standards, regulations and industry guidance.
Benefits of Medical Device Design History file and Tech File remediation include:
· Experts for each respective area, for example: Risk Management, Verification and Validation, Biocompatibility, Regulatory compliance, etc.
· Dedicated team, tailored to your project, built to minimize disruption of internal resources
· Project plan and weekly updates on progress
· Right First Time – as we have conducted many remediation projects, you can rest assured the quality and compliance will be done correctly and efficiently