Decus Biomedical

What Decus Biomedical does

Decus Biomedical is a Berkeley, California-based medical device consulting firm founded in 2004 by CEO and Principal Consultant Grace Bartoo. The firm provides regulatory, clinical, and quality consulting services to medical device companies, with stated expertise in FDA 510(k) clearance, PMA approvals, CE Mark technical files, Health Canada submissions, IEC 62304/82304 software compliance, and clinical trial design and execution. Approximately 80% of clients are startups and the remaining 20% are multi-national corporations; the firm reports having served over 150 different medical device companies since inception.

The company operates two core service lines. Decus Consulting delivers project-based regulatory submissions, design documentation, Quality System establishment and audits, clinical trial support, and software compliance assessments. Decus CQO (Contract Quality Organization) is a managed, subscription-based Quality System offering with tiered plans aligned to the client's product development phase; it includes pre-configured SOPs, templates, and an electronic document control system validated for 21 CFR Part 11 compliance, intended as a turnkey solution that lets startup engineering teams focus on product development rather than quality procedures.

The firm is privately held, bootstrapped, and founder-owned, with no external funding rounds or institutional investors reported. A 9-person team — comprising the CEO/Principal Consultant, a Senior Consultant, Product Development Specialist, Verification Engineer, Senior Quality Associates, a Senior Regulatory Associate, a Quality/Regulatory Assistant, and an Accountant — delivers services through direct client engagement, supported by a website and client referrals as primary acquisition channels. Notable long-tenured clients include Siemens Healthineers, VisioPharm (8+ years), APN Health (7 years), Koa Health, Ancora Medical Technologies, and Opticyy.

Name

Decus Biomedical

Legal name

Decus Biomedical Inc.

Website

https://decusbiomedical.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

1–10 employees

Short description

Decus Biomedical is a Berkeley-based medical device consulting firm that provides regulatory, clinical, and quality services — including FDA submissions, Quality Systems, and clinical trial support — primarily to medical device startups (80% of clients), plus a subscription-based CQO Quality System product.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Consulting

akta.pro primary industry

Regulatory Submissions & Clinical Content Management (eCTD/Publishing) (HLACAOAN)

akta.pro secondary industry

Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

Keywords

• Medical device consulting
• Regulatory affairs services
• Quality system implementation
• FDA submission support
• Clinical trial services

Headquarters

HQ city

Berkeley

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. CQO Subscription Services: Managed, subscription-based Quality System services with tiered plans corresponding to client's phase of product development. Includes procedures, templates, electronic document control, training, and ongoing support.
2. Regulatory Consulting: Project-based consulting for regulatory submissions including 510(k), De Novo, PMA, CE Technical Files, Health Canada submissions, FDA pre-submission meetings, and regulatory strategy planning.
3. Quality System Consulting: Quality System establishment, improvement, and audit services including internal audits, gap analyses, supplier audits, and FDA inspection preparation.
4. Clinical Trial Services: Full clinical trial support including study design, protocol development, clinical operations, site selection, monitoring, and clinical study reports.
5. Software Quality Services: IEC 62304 and IEC 82304 compliance assessments, software procedures and templates development, and verification/validation services.

Pricing tiers

Go-to-market motion1 record

Distribution channels2 records

Marketing channels3 records

Core offering

Decus Biomedical provides regulatory, clinical, and quality consulting services to medical device companies, including FDA 510(k), De Novo, and PMA submissions, CE Mark technical files, Health Canada submissions, design documentation, clinical trial design and execution, and Quality System establishment. The company also offers CQO (Contract Quality Organization), a managed, subscription-based Quality System with pre-validated electronic document control configured for 21 CFR Part 11 compliance, providing procedures, templates, training, and document control staffing for medical device startups.

Product overview

Decus Biomedical offers two core products: Decus Consulting for regulatory, clinical, and quality advisory services, and CQO (Contract Quality Organization) for managed, subscription-based Quality System implementation. Decus Consulting provides strategic planning, FDA/CE/Health Canada submissions, design documentation, software compliance (IEC 62304, IEC 82304), clinical trials, and Quality System development. CQO delivers turnkey Quality System solutions with pre-configured SOPs, templates, electronic document control, and services including document control staffing and training—allowing clients to focus on product development while outsourcing Quality System management.

Differentiator

Problem solved

Functional benefit

Brands

• Decus CQO: Contract Quality Organization service offering - a managed, subscription-based Quality System providing standard operating procedures, templates, electronic document control, and quality process tools for medical device start-ups.

Products and services

• Decus Consulting Regulatory, clinical, and quality consulting services for medical device companies worldwide. Includes strategic planning, FDA submissions (510(k), De Novo, PMA), CE Mark technical files, Health Canada submissions, FDA pre-submission meetings, design documentation, software compliance (IEC 62304, IEC 82304), clinical trials, and Quality System establishment, improvement, and audits.
• CQO (Contract Quality Organization) Managed, subscription-based Quality System providing standard operating procedures, guidance-filled templates, electronic document control system with digital signatures (pre-configured and validated for 21 CFR Part 11 compliance), quality process tools, regulatory and project management services, training, document control staffing, and progress reporting. Tiered subscription plans correspond to the client's phase of product development.

Quantifiable outcome

• 80% of clients are startups, demonstrating strong fit for early-stage medical device companies
• +3 more outcomes

Named customers6 records

Segments3 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Market position

Competitive moat4 records

Key highlights6 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Decus Biomedical