Remember the old saying, “Cross all the T’s and dot all the I’s?” Well, that’s a fundamental aspect of design control.
If you haven’t delved far into it, you’ll quickly discover that design control can be daunting. This is, after all, a formal plan for the design of your medical device or product. The details are many – and devils can lurk within.
If you’re feeling overwhelmed – or intimidated – by the seemingly infinite records in design control, SpectraMedEx can relax your load. We’ll create a design history file and all its deliverables. Having been involved in medical device development for three decades, we know the records to keep, how they should be changed, and all the verifications involved.
If your design history file is complete, we’ll audit whether it’s compliant with industry expectations and potential outside audits. We also offer design remediation to review and fix gaps in documentation and processes.
Some people are naturally detail-oriented. Others aren’t. No matter where you fall on the spectrum, don’t pull out your hair trying to decide which details matter in design control. SpectraMedEx ensures that what needs to be crossed is crossed, and all the dots are correctly placed.