Control the Life Sciences Data Ocean
Navigate the life sciences data ocean with confidence.
Drive product success throughout the entire lifecycle utilizing data-driven insights, ensuring
the safety and performance your customers expect.
Why use Orca1
Your Single Source of Truth for Life Sciences Intelligence
Orca1, a revolutionary MedTech intelligence platform that empowers users
with the combined power of human expertise, AI, and advanced automation.
Orca1 ingests and curates billions of real-world, real-time data
sources and provides users with a centralized hub loaded with valuable insights.
State-of-the-Art, Simple, Powerful
Arcana
Search Engine
The ocean of knowledge is at your fingertips. Explore billions of
structured
data attributes from diverse sources - regulators, clinical trials,
scientific publications, manufacturer websites and more.
Argus
Active Surveillance
Harness the power of structured data sets to monitor your products and
markets.
Actively scrutinize trends, changes, and risks, to ensure compliance
throughout your products entire Total Life Cycle.
Bot
Automation
Streamline your product compliance processes.
Automate registrations, submissions, UDI, adverse event reporting, and
more,
ensuring accuracy and efficiency.
Scribe
Your Notebook
Master the waves of information.
Organize your notes effortlessly with intuitive tags and folders.
Find anything with powerful search.
Collaborate seamlessly with your team.
OrcaAI
AI Models
Get authoritative answers with Orca1 Global Regulatory AI Copilot.
Simplify your Orca1 data queries well beyond our advanced Natural
Language Searches (NLS).
OrcaAPI
API Integration
Do you like what you see? Would you like to see it in your own
application or platform?
Integrate any Orca1 information with your own application(s).
Who We Serve
Together, We Elevate Patient Outcomes Through Life Sciences Intelligence and Innovation.
Arcana
Search and See What Others Can't.
The ocean of knowledge is at your fingertips. Explore billions of structured data attributes from
diverse sources - regulators, clinical trials, scientific publications, manufacturer websites and
more.
Search Deeper, Discover More
Advanced natural language processing features help you search with precision, even when
your
criteria is complex.
Powered by billions of constantly updated attributes from global sources, your searches
retrieve the most complete and current information.
Get the insights you need. Our data science team meticulously ensures the accuracy and
relevance
of curated information, empowering you to make informed decisions.
- Submissions
- Registrations
- Adverse Events/ Recalls
- Inspections
- Warning letters
- Clinical trials
- Literature
- Guidance and Standards
Argus
Active Surveillance, Intelligent Insights
Harness the power of structured data to continuously monitor your product and market.
By actively scrutinizing trends, changes, and risks, you can ensure compliance throughout
your product's entire Total Life Cycle.
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Predictive & Preventative Monitoring
Extract meaningful information from real-world data
Utilize cutting-edge solutions for data acquisition, cleaning, and structuring
Generate real-time insights for informed decision-making
- Device life-Cycle
- Industry Documents
- Establishment Compliance
- Investigator Profiles
BOT
Tame the Regulatory Beast.
Streamline your product compliance processes with our digital platform.
Automate registrations, submissions, UDI, adverse event reporting, and more, ensuring accuracy and
efficiency.
Work Smarter, Not Harder
Execute tasks according to pre-defined sequences, eliminating constant manual
intervention.
Ensure consistency and accuracy through predefined rules, minimizing the risk of errors.
Unlock your full potential for strategic decision-making by streamlining repetitive
tasks.
- GUDID (coming soon)
- eSTAR (coming soon)
- eSubmitter (coming soon)
- Eudamed (coming soon)
- FDA Registration (coming soon)
- MDR Classification Assessment- (coming soon)
- Systematic Literature Review (coming soon)
SCRIBE
Effortless Organization, Powerful Collaboration
Master the waves of information. Organize your notes effortlessly with intuitive tags and folders.
Find anything with powerful search. Collaborate seamlessly with your team.
Note Taking, Reinvented
Organize and curate your knowledge: Capture, record, and categorize information to build
your own personalized library.
Find the information you need instantly with a robust tagging system and search
functionality.
Collaboration made easy, share notes seamlessly and work together in real-time.
OrcaAI
The Future of Intelligence: Humans and Machines Working Together
Navigate effortlessly chatting with OrcaGPT. Trained on regulatory and guidance information from
many countries, and your own uploaded documents and files, OrcaGPT is your global regulatory AI
copilot.
Intelligence at your Fingertips
Ask complex regulatory questions in plain language, get precise answers backed by source
citations.
Interrogate your own documents for compliance gaps and insights with AI assistance.
Stay ahead of regulatory changes.
Pricing
Testimonials
A Boutique Law Firm which Specializes in FDA Regulations
Thanks for the demo on how to navigate Orca1’s platform. A comparable search in our current
Basil system would have taken me hours, in Orca1 it took minutes.
Expert Consultant, Ex FDA Deputy Director, Digital Health FDA
Safe to say Orca1 is considerably more sophisticated than what I put out and anything the
FDA is doing! Your prices are too low!
A Leading Graduate Medical School
It took us over 2 weeks to collect the information needed for our MDER paper. Orca1 provided
this information in minutes. I am so excited to access all the data on your platform!
A Full-Service Consulting Business for the Medical Device Industry
I have been using the Orca1 Digital Intelligence Platform for the past year. This has been a
great tool to help me with a variety of quality and regulatory activities.
In one case when it seemed certain that a device was going to require a De Novo, the Orca1 platform allowed me to find a predicate device that had similar indications for use and technology, which saved a considerable amount of time for research and both time and money by supporting a 510(k) submission instead of a De Novo.
The tool for reviewing company compliance history including past inspections, warning letters, recalls and adverse events reports allowed fast and useful information to be accessible in preparation for a Due Diligence audit.
In one case when it seemed certain that a device was going to require a De Novo, the Orca1 platform allowed me to find a predicate device that had similar indications for use and technology, which saved a considerable amount of time for research and both time and money by supporting a 510(k) submission instead of a De Novo.
The tool for reviewing company compliance history including past inspections, warning letters, recalls and adverse events reports allowed fast and useful information to be accessible in preparation for a Due Diligence audit.
One of the World's Top Law Firms
Our client, facing their first FDA on-site inspection for a PMA product, was very
inquisitive to understand the process and the expectations. As part of the planning stage,
we contacted Orca1 to obtain a comprehensive intelligence profile of the assigned
investigator. This insightful information empowered us to address potential concerns and
navigate the inspection smoothly, resulting in no 483 observations. With this hurdle cleared
we can now focus our attention back on bringing this innovative product to market.
Thanks again Orca1
Thanks again Orca1
An Early-Phase Medical Device Inventor and Manufacturer
Orca has been an instrumental tool guiding the regulatory strategy of the company. The
platform allowed me to effortlessly identify a predicate device that was ultimately used for
our FDA Q-sub. Furthermore, the user interface allows you to conduct broad searches in
minutes that used to take hours on the traditional FDA website.
Benefits
Risk Profile
- Proactively identify risks: Uncover potential safety concerns, adverse events, or quality issues early on, mitigating threats before they become major problems.
- Risk scores: Orca1's predictive analysis tools provide device-specific risk scores, highlighting areas for attention and aiding in prioritization.
- Risk trends: Track risk scores over time, offering insights into improving device safety and overall portfolio health.
Active Surveillance
- Real-time awareness: Get instant notifications for emerging issues related to your devices, competitors, or relevant technologies.
- Customized alerts: Define precise parameters for surveillance, filtering out noise and focusing on signals that matter most to your organization.
- Comprehensive monitoring: Track approvals, regulatory actions, adverse events, recalls, literature, clinical trials, UDIs, and more - across global sources.
Regulatory Submissions
- Efficient predicate searches: Easily find relevant predicates and build streamlined regulatory arguments with extensive reference resources.
- Streamlined clearance and approval: Utilize historical data and insights to increase submission success and mitigate approval delays.
- Global regulatory expertise: Navigate multiple regulatory frameworks to ensure international compliance.
Product Design and Development
- Improve device safety: Integrate historical data and risk insights directly into the design process to address potential issues proactively.
- Innovation insights: Access a broader knowledge base for design breakthroughs and novel regulatory strategies.
- Accelerate time-to-market: Informed by regulatory landscapes, reduce rework and ensure efficient submission pathways.
Competitive Research
- Market landscape understanding: Deep-dive into competitor devices, regulatory pathways, approvals, and safety profiles.
- Benchmark your devices: Compare your performance to others in the field, identifying strengths, weaknesses, and competitive gaps.
- Trendspotting: Detect shifting regulatory requirements, industry trends and emerging technologies for long-term strategic planning.
Quality Assurance
- Comprehensive inspections data: Analyze 483s, warning letters, and other inspection documents to avoid similar violations within your organization.
- Compliance confidence: Compare device classification and regulations against similar devices to verify appropriate practices.
- Data-driven remediation: Identify systemic quality issues and develop targeted action plans with insights from across the industry.
Due Diligence & M&A
- Comprehensive assessments: Quickly but thoroughly evaluate target companies or acquisition candidates on the strength of their device portfolio.
- Risk quantification: Understand regulatory liabilities, quality risks, and product safety profiles related to target devices.
- Informed valuation: Make data-backed decisions about investment values, leveraging the historical market information on Orca1.
AI-Powered Insights
- Faster research: OrcaGPT utilizes natural language processing for more intuitive searches, delivering tailored answers with verifiable reference links.
- Customizable searches: Ask for highly custom arrangements of information allowing for deeper and otherwise unattainable insights.
- Data-driven decision making: Cut through complexity with advanced analytics, predictive models, and AI-generated summaries.
Publications
Orca1 Publications: Where Stories Surface
FDA Public Submission Comments - Selecting a Predicate Device
Agency Food and Drug Administration| Posted Dec 7, 2023| ID FDA-2023-D-3134-0043
Orca1 Comments- FDA-2023-D-3134, Best Practices for Selecting a Predicate Device to
Support a Premarket Notification [510(k)] Submission; Draft Guidance for Industry and
Food and Drug Administration Staff
Recall and Predictive Trends Analysis in Orca1
The medical device industry faces challenges with recalls. Our predictive analysis
system quantitatively predicts recalls with over 92% accuracy, benefiting stakeholders
for proactive safety measures.
Posts and Comments on Professional Forums
Meet our Advisors
Joe Mullings
Chairman & CEO / MedTech's Top Search Consultant /The Mullings Group Companies/Board Member/Angel Investor/Keynote Speaker
ProfileDavid Pudwill
Mr. Regulatory | Former FDA | Fractional Chief Regulatory Officer | Consultant | Medical Device and Combination Product Expert
ProfileJames E. Tcheng, MD
Professor of Medicine | Associate Dean for Academic Appointments | Professor of Family Medicine and Community Health | Cardiology | Duke
ProfileJoseph Azary MBA CQA CMDA
Chief Advisor & Compliance Officer for Aztech Regulatory & Quality, providing consulting services to the medical device industry.
Profile