Design Changes During Regulatory Submission

MattT

Registered
Good day everyone,

I would just like to see how everyone manages future work during technical file submission for regulatory review. Design work can clearly not pause during the regulatory review process due to how long it can take. What are some best practices at managing documents that might change or require updating as designs are improved? How does one manage revisions (in light of the fact that you may need a quick change during the audits to address any concerns)?

Look forwards to your response
 

shimonv

Trusted Information Resource
Every change needs to be reviewed on its own, taking into account the respective guidance documents that define which change requires a regulatory submission.

If you get a chance submit changes ("improvements") during the regulatory review process - go for it!
 

Aliken

Involved In Discussions
Good day everyone,

I would just like to see how everyone manages future work during technical file submission for regulatory review. Design work can clearly not pause during the regulatory review process due to how long it can take. What are some best practices at managing documents that might change or require updating as designs are improved? How does one manage revisions (in light of the fact that you may need a quick change during the audits to address any concerns)?

Look forwards to your response
Design work is not always a continuous activity; you may consider "freezing" this activity while TD documentation is under review.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Regulatory agencies are concerned with the current standard of care or device performance. If you submit a device with performance metrics and then update the performance of your device substantially this is something regulators are interested in knowing about.
 
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