Decus Services Page

Decus Services

Decus Biomedical, LLC can provide your company with outsourced regulatory, clinical, quality and research services for biomedical devices. We have expertise in software and electromechanical devices, with particular experience in imaging technologies. Over the past few years we have worked primarily with startup companies, and have provided our clients with the following services:

Regulatory Strategy

Clinical Trials

Software Quality Services

Quality System Services

Regulatory Strategy TOP

Decus has a proven track record with successful FDA outcomes. We have helped multiple clients in the following areas:

	Strategic planning
	510(k) submissions
	Investigational plans and clinical protocols
	PMA submissions
	FDA export approvals
	Preparation and guidance for FDA inspections

Clinical Trials TOP

Decus has a proven track record with planning and executing successful clinical studies that can be used in FDA submissions. We have helped multiple clients in the following areas:

	Study and protocol design
	Investigator brochures
	IRB/Ethics Committee approvals
	Case Report Form design
	Study management and monitoring
	Good Clinical Practices compliance
	Data management
	Data analysis and reports
	US and international trials
	FDA BIMO inspections

Software Quality Services TOP

Decus has a team of highly experience medical device software engineers that have helped multiple clients establish their software development processes and ensure compliance with FDA regulations relating to software - especially 21 CFR 820.30 - Design Control and 21 CFR 11. Decus has worked with clients that have a software-only products and embedded firmware. Some of the services we have provided in the past include:

	Establish development process with emphasis on IEC 62304 standard for software
	Establish and maintain software configuration management processes
	Establish and maintain defect tracking processes
	Establish verification and validation plans and conduct the tests/activities
	Establish and conduct risk management process compliant with ISO 14971
	Establish processes to ensure companies comply with FDA electronic records and signature requirements (21 CFR Part 11)
	Write software sections of FDA submissions (510(k), PMA)

Quality Systems Services TOP

Decus has helped multiple start up companies establish their quality systems in compliance with FDA regulations for medical device companies as well as in compliance with ISO 13485. Decus has also helped integrate quality systems when companies merge. Key services provided include:

	Planning a Quality System from scratch
	Writing Quality Manuals, Standard Operating Procedures, and Work Instructions
	Implementing Quality System SOPs
	Providing Staff Training
	Conducting Gap Analyses, Internal Audits, Supplier Audits
	FDA Inspections
	Maintaining Document Control and CAPA systems
	Preparing and organizing company's design control documentation