Haylee Bosshard

Haylee is the CEO and founder of Conformify and has worked in the medical devices industry for a number of years. Haylee is on a mission to help companies to build effective, light-weight quality and regulatory processes that bring their medical device to market efficiently and with the highest quality.

Products:

SOP Change Control Bundle_image
Haylee Bosshard

SOP Change Control (Bundle)

This is a change control standard operating procedure bundle. It includes a change control SOP template along with all supporting documents such as: change request template, action plan template, and verification results template. We designed it for medical device companies that want to fast track documenting their change control procedure. It is compatible with ISO 13485, the EU Medical Device Regulations 2017/745 and/or the FDA 21 CFR 820.

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Blog Posts:

How to modularize your documents
Haylee Bosshard

Quick Tips: How to Modularize Documentation

Documents in a medical device file may require duplicate information. For example, the intended use is a statement that appears in many documents such as the device description, project plan, risk management plan, or sterilization validation, etc. Modularizing the documents may improve your documentation quality by avoiding copy paste errors, but may also reduce the time needed to copy and paste as well as review burden.

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View Standards for Free
Haylee Bosshard

How to View Standards for Free

Need to check the content of a standard before purchasing, so that you know whether or not it applies to your product? Or perhaps you want to clarify a reference to a standard in a document sent to you by one of your suppliers? You can access the many standards for free!

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Courses: