Decus Biomedical providesregulatory, qualityand clinical consulting services for Class I, II and III devices. Our expertise is in medical devices containing software. Our niche market consists of the small, start-up companies because we are fast, efficient and flexible. We are experienced in providing product support from the initial regulatory strategy, quality systems support, clinical trials, FDA (both 510(k) and PMA), Canada and EU submissions all the way through product launch and post-market surveillance.
Regulatory
Clinical
Qulity
Software Quality

Regulatory

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
_international
· More...

Clinical

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 design
· Clinical operations
· Data management
· Study monitoring
· More…

 

Quality

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 regulation
_(e.g. 820, 11, 812)

· Compliance to ISO 13485
· Compliance to 62366
· FDA, CA, State and Notified Body
_ Inspections
· More…

 

Software Quality

The Decus staff includes core competencies in software development and software quality.(More)...

· Establish IEC 62304 compliance
· Provide software tool validation
_ (e.g. 21 CFR 11 compliance)

· Write verification and validation
_plans and procedures

· Risk Management compliance with
_ISO 14791
· More…

Copyright © 2012 Decus Biomedical, LLC | 2342 Shattuck Ave., #333 Berkeley, CA 94704 | Office (650) 488-7799 Fax (650) 204-6819