Freeing You to Innovate

Bioscience Pro simplifies the complex and time-consuming process of software documentation, risk analysis, verification and validation. We take care of this so you can do what you do best: innovate.

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Our Expertise

Software documentation per IEC 62304
- System Requirement Specifications
- Software Requirement Specifications
- Software Architectural Design
- Software Design Specifications
Software Validation and Verification per IEC 62304
Software Hazards Analysis and Risk Management per ISO 14971
Software Traceability per IEC 62304
Cybersecurity Risk Management per AAMI TIR 57
HIPAA and GDPR auditing

Project Inspection

We analyze your project’s or product’s current documentation and regulatory status.

Team Integration

We get to know the code and your engineering team.

Live Documentation

We create a constantly-updated plan for keeping documentation fresh, accessible and relevant.

Round-trip Excellence

We ensure that your documentation and regulatory exposure is ahead of the curve.

Investor Services

Do you know how far the startup is from a 510(k) submission or clearance?
Are you aware of the FDA’s requirements to clear a software system in a
medical device?
Does the startup have a software process or enough level of expertise to
satisfy the FDA’s 510(k) submission requirements for the software?

Bioscience Pro provides due diligence services to evaluate the existing
software engineering, software quality management processes, and Design
History File. We conduct interviews with the engineering personnel and
provide a realistic picture of where exactly the startup is in readiness to
receive or submit a 510(k).

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We Take Pride in Our Numbers

Years of Experience

Rejected FDA 510(k) Submissions

500K

Lines of Code Documented

Regulatory Surveys Completed per Week

Our Clients Are Talking...

Jorey Chernett - Intrinsic Medical Imaging LLC

"Bioscience Pro has meticulously engineered our software documentation based on sound engineering principles which turned our submission into a definite success."

Eran Bashan - Hygieia LLC

"Bioscience Pro provides this unique quality to connect the Quality Systems Management team with the Software Development team. The documentation provided by Bioscience was key to our success in receiving the 510(k) clearance."

Paul Angott - CEO First Sense Medical

"Bioscience Pro provided us with unique expertise to create our Software Documentation. We received a Traditional and Special 510(k) clearance from FDA back to back with Bioscience help."

Are You Ready to Get Back to Innovating?

Sample Projects

A few of the many engagements we have successfully completed:

TALIS Biomedical, Menlo Park CA

Point-of-Care Diagnostic Testing, Rapid COVID Test Device

Project Scope: Software, and V&V documentation.

Seraph Biosciences, Detroit MI

Realtime pathogen Detection Point-of-Care Diagnostic Testing, Rapid COVID Test Device

Project Scope: Software, V&V, and Software Risk Management documentation.

Mindset Medical

Telehealth System, Remote vital signs measurement.