The probability of a hazardous situation is <0.000025. To get this result, we simply multiply the three events within the sequence. So, while swimming near a great white shark and having a 25% chance that it will target you for attack, the likelihood of your (make-believe) shark repellant device having activation button failure is so low that it significantly reduces the risk of actually being in a hazardous situation. We use calculations like this in risk management assessments of our clients’ (real) combination products.

To read more on the subject, check out our article Risk Management Assessment Calculations for Combination Products.

The missing documents are Design Outputs, Change Control, Design Transfer, and Usability Engineering File. Once you gain clarity on the regulatory requirements of your particular combination product, it is a good idea for a knowledgeable expert to create a Design History File (DHF) Index. Doing so at the outset of the project will ensure the necessary information in captured and documented within the final DHF.

To read more on the subject, check out our article Creating A Design History File (DHF) That Gets Approval

To offset reduced ability to audit as a result of purchasing “off the shelf” components or drug delivery device constituents, industry best practices tells us it is a good idea to do all of the following:

• Conduct further testing to supplement incomplete information, including
  usability and incoming release testing.
• Have an agreed-upon change notification process and ALSO monitor for changes
  internally.
• Consider safety stock inventory.
• Conduct due diligence and quality monitoring in lieu of audits.

These actions are also good strategies to offset other “off the shelf” product quality management limitations, such as inadequate visibility to upcoming changes, quality concerns or supply issues, and inability to get access to complete information and documentation “off the shelf” items, particularly if you are using the item in a different way for which it was originally designed by the manufacturer.

Want more tips on effective quality management of your suppliers? Read our article “Are You Managing Your Combination Product Supplier Relationships Well Enough?”

There’s no right–in–every–situation answer here. What is important is the process that you go
through to identify the risk and the potential costs or additional resources required
if your supplier falls short in any of these areas.

For more of Suttons Creek’s recommended selection criteria, read our article “Nine Ways To
Make Sure You Are Selecting The Right Device Constituent Supplier”

Drug Development (QbD) calls it a Master Project Plan, but Device Development (Design Controls) calls it a Design & Development Plan.

Device Development (Design Controls) calls it Human Factors, but Drug Development (QbD) calls it Guidance on Medication Errors.

Drug Development (QbD) calls it Characterization / Stability, but Device Development (Design Controls) calls it Design Verification.

Device Development (Design Controls) calls it a Design History File, but Drug Development (QbD) calls it a Product Dossier & Development Report.

Here are a few more similar functions that are called something different in Drug Development (QbD) v. Device Development (Design Controls):

Master Project Plan v. Design & Development Plan

Quality Target Product Profile v. User Needs & Design Inputs

CQA, Control Strategy v. Design Outputs

CMC Stage Gate Reviews v. Design Reviews

Characterization / Stability v. Design Verification

Clinical Studies v. Design Validation

Guidance on Medication Errors v. Human Factors

Technology Transfer v. Design Transfer

Product Dossier & Dev. Reports v. Design History File

Master Batch Record v. Device Master Record

Risk Management ICH Q9 v. Risk Management ISO 14971

Change Control v. Design Change Control