Activities related to clinical research that are considered qualified include:
- Clinical studies/investigations performed in-house or by outside Contract Research Organizers (CRO) in the US.
- Preparing and collecting documentation required for regulatory submissions and internal research files.
- Doctors or other scientists serving in a consultative role as part of the clinical research process.
Activities related to medical devices that are considered qualified include:
- Designing/Engineering new product designs.
- Modeling/building/testing prototypes.
- Performing manufacturing test runs on new products.
- Modifying manufacturing processes to improve quality, speed, yield, and efficiency to reduce cost, and reduce waste.
- Testing (including sterility and QA) prior to regulatory approval.
- Serving as a liaison between customers and the development team to identify desired design improvement
Activities related to the medical industry that DO NOT qualify include:
- Manufacturing of existing products.
- Repairs, maintenance, and bug-fixes.
- Customer technical support or helpdesk.
- Post-approval/release analysis and testing.
- Other non-R&D related matters (HR, management, budgeting, marketing, customer relations, training, 2nd level and above management, etc.)
- Post-market research/surveillance, market research, customer education.
- All employee/contractor time spent working outside the US.
Please contact the MASSIE team if you want to discuss this topic further or require assistance with your calculations.
Disclaimer: The information on this website is for general information purposes only. Nothing on this site should be taken as legal advice for any individual case or situation.
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