👔 Organisation Charts
☀️ Summary
Nothing too complex here, just a nice and simple organisation chart template for you. For Free. Of course.
➕ Additional Information: Organisation Chart Template
💸 FDA Small Business Discount
☀️ Summary
Anyone who has been through an FDA application will be aware of the costs associated with it, never mind the actual cost of becoming ready to apply but they also have the additional audacity to charge you for the privilege of applying.
I am just kidding, FDA. I love you really 😶
Anyway, I digress.
The standard fee for a 510k application is $12,432. However, if you qualify as a small business, your application fee measley $3,108.
A small business is defined as a business, including its affiliates, whose gross receipts and sales are less than $100 million for the most recent tax year.
Additionally, a small business is eligible for a "first premarket application/report" fee waiver, if the business/affiliate gross receipts or sales are no more than $30 million. The "first premarket application/report" is defined as the first PMA (including Modular PMA), BLA, PDP, or PMR received by the FDA from a business entity or any of its affiliates.
Applying is pretty simple, check out the link in our additional information below and the FDA will show you the way.
➕ Additional Information: Reduced Medical Device User Fees: Small Business Determination (SBD) Program
📋Audit Checklist
☀️ Summary
If you’re going into audits with a blank notepad, you’re setting yourself up for a nightmare of trying to compile an audit report.
We’re quality professionals, so we need to practice what we preach and prepare.
Enter audit checklist, this just gives you an easy way to document your audit, evidence and findings as you go making for a more effective audit report and ultimately a better follow up and closure.
➕ Additional Information: Audit Checklist Template