Decus Biomedical
Decus Biomedical is a company with extensive experience in medical device consulting, offering tools and services to support medical device companies throughout their product lifecycle. They provide regulatory, clinical, quality, and software development expertise, with a focus on helping start-ups and established companies achieve successful market entry and compliance.
Industries
Nr. of Employees
small (1-50)
Decus Biomedical
Berkeley, California, United States, North America
Products
Regulatory interaction tracker (web tool)
Web-based tool to capture and maintain regulatory events, dates, notes and files associated with regulatory interactions in a centralized location.
Submission completeness checker (RTA checklist tool)
Web-based submission checker to assess 510(k) submission completeness and generate refusal-to-accept (RTA) checklists prior to filing.
Subscription-based managed Quality System (CQO product)
Packaged offering combining SOPs, templates, validated electronic document control, training, and document control staffing delivered as a subscription-aligned to product development phases.
Regulatory interaction tracker (web tool)
Web-based tool to capture and maintain regulatory events, dates, notes and files associated with regulatory interactions in a centralized location.
Submission completeness checker (RTA checklist tool)
Web-based submission checker to assess 510(k) submission completeness and generate refusal-to-accept (RTA) checklists prior to filing.
Subscription-based managed Quality System (CQO product)
Packaged offering combining SOPs, templates, validated electronic document control, training, and document control staffing delivered as a subscription-aligned to product development phases.
Services
Consulting services for regulatory strategy, preparation and management of submissions and agency interactions across major jurisdictions and submission types.
Turnkey Quality System implementation as a managed, subscription-based service including SOPs, templates, training, document control staffing, and validated electronic document control.
End-to-end clinical support including protocol design, site selection, monitoring, eCRF design, data management and clinical study reporting.
Assessment and remediation for software medical devices including compliance with IEC standards, software verification/validation, tool lifecycle management, and 21 CFR Part 11 considerations.
Consulting services for regulatory strategy, preparation and management of submissions and agency interactions across major jurisdictions and submission types.
Turnkey Quality System implementation as a managed, subscription-based service including SOPs, templates, training, document control staffing, and validated electronic document control.
End-to-end clinical support including protocol design, site selection, monitoring, eCRF design, data management and clinical study reporting.
Assessment and remediation for software medical devices including compliance with IEC standards, software verification/validation, tool lifecycle management, and 21 CFR Part 11 considerations.
Expertise Areas
- Regulatory strategy and submissions
- Quality system implementation and management
- Software medical device quality and compliance
- Clinical trial design and execution
Key Technologies
- Electronic document management systems (validated for 21 CFR Part 11)
- Software lifecycle processes aligned to IEC 62304 and IEC 82304
- Clinical data capture (eCRF) and clinical data management systems
- Usability engineering and human factors methods
News & Updates
Testimonials from clients highlighting Decus Biomedical's collaborative approach, expertise, dependability, and successful project outcomes.
Information about Decus's consulting services across regulatory, clinical, quality, and product development areas.
Web-based tools for regulatory management, including Tracker and Checker, provided by Simplifydi.com.
Testimonials from clients highlighting Decus Biomedical's collaborative approach, expertise, dependability, and successful project outcomes.
Information about Decus's consulting services across regulatory, clinical, quality, and product development areas.
Web-based tools for regulatory management, including Tracker and Checker, provided by Simplifydi.com.