Decus has a proven track record with successful FDA outcomes. We have helped multiple clients achieve the following:(More)...
· 510(k) clearances
· PMA approvals
· Successful pre-IDE meetings
· Strategic regulatory plans
· Product Recall-Domestic and
Decus can help you prepare and execute an entire clincal trial or we can support your team. Our study experiences have included multi-national, multi-site studies, (More)...
· Study and protocol
· Clinical operations
· Data management
· Study monitoring
Decus has helped many clients establish and/or improve their quality systems which has enabled our clients to pass FDA inspections,(More)...
· Compliance to FDA
_(e.g. 820, 11, 812)
· Compliance to ISO 13485
· Compliance to 62366
· FDA, CA, State and Notified Body
The Decus staff includes core competencies in software development and software quality.(More)...
· Establish IEC
· Provide software tool validation
_ (e.g. 21 CFR 11 compliance)
· Write verification and validation
_plans and procedures
· Risk Management compliance with