Bring Medical Devices to Market.
We’ll Maintain eQMS Files, Track 510(k) Submissions & Prep Clinical Trials.
Stop losing 25+ hours a week to manual Design History File (DHF) indexing, cross-referencing ISO 13485 audit logs, formatting IRB submission binders, compiling reimbursement CPT/HCPCS code databases, and assembling investor data rooms. Get an elite, healthcare-fluent MedTech Virtual Assistant supervised by one dedicated Project Manager at zero extra cost.
100%
ISO 13485 & FDA 21 CFR 820
$0
Free Dedicated PM Oversight
< 24 Hrs
DHF Document Turnaround
Zero
Confidential IP & Patent Leaks
Dedicated Project Manager
Regulatory & Quality Sentinel
MedTech Venture Command · Live Queue
Greenlight Guru, MasterControl, PitchBook & ClinicalTrials
Indexed 18 verification protocols into Greenlight Guru eQMS; verified trace matrices linking user needs to engineering specs.
Assembled informed consent forms (ICF), clinical trial protocols, and investigator brochures for institutional review board submission.
Reconciled patent filing timelines, Freedom to Operate (FTO) opinions, and NIH Phase II grant milestone reporting in DealRoom.
Dedicated MedTech Virtual Assistant
$6 / Hour
Zero Audit Surprises
Full Focus on Innovation
Fluent in Greenlight Guru, MasterControl, Qualio, FDA CDRH & ClinicalTrials.gov
Our virtual assistants understand the high-stakes compliance language of medical technology: Design Controls (21 CFR 820.30), ISO 14971 risk management, 510(k) predicate device crosswalks, Software as a Medical Device (SaMD) IEC 62304 lifecycles, and CMS reimbursement pathways. Zero training drag.
eQMS & Quality Systems
Design controls, CAPA management, document change orders (DCO), and supplier quality files.
Regulatory, Trials & Patents
FDA 510(k) databases, trial registry reporting, patent FTO searches, and EDC audits.
Reimbursement & Market Access
CPT/HCPCS code indexing, hospital DRG coverage models, and commercial payer policies.
VDR, Grants & Data Security
NIH SBIR/STTR grant compliance, investor diligence rooms, and encrypted IP vaults.
What Your MedTech Virtual Assistant Executes Daily
Stop getting bogged down by bureaucratic document routing, manual ISO traceability tables, and unorganized clinical trial folders. Let your engineers build prototypes, your clinicians run trials, and your executives close venture capital rounds.
Design History File (DHF) & eQMS Management
FDA 21 CFR 820.30 and ISO 13485 require continuous design control traceability. Your assistant maintains your Design History File (DHF), logs Document Change Orders (DCOs) in Greenlight Guru or Qualio, and manages Device Master Record (DMR) versioning.
- Linking User Needs, Design Inputs, Outputs, Verification & Validation (V&V) matrices
- Routing Engineering Change Orders (ECOs) and training sign-offs across team members
- Maintaining approved vendor lists (AVL) and supplier qualification audits
FDA 510(k) Pre-Market Submission & EU MDR Prep
Preparing pre-market notifications requires hundreds of supporting exhibits. Your VA benchmarks predicate devices in the FDA 510(k) database, drafts substantial equivalence comparison tables, compiles biocompatibility (ISO 10993) test reports, and formats eSTAR submission packets.
- Pulling predicate 510(k) summary PDFs and product codes (Procodes) from FDA databases
- Formatting technical documentation exhibits into official FDA eSTAR digital templates
- Assembling Clinical Evaluation Reports (CER) and GSPR matrices for EU MDR Notified Bodies
Clinical Trial Operations & IRB Submission Management
Clinical validation and pivotal IDE trials involve heavy multi-site operational overhead. Your assistant formats Institutional Review Board (IRB) packages, updates ClinicalTrials.gov registries, tracks patient enrollment pacing, and manages Trial Master File (TMF) logs.
- Submitting protocol amendments, Informed Consent Forms (ICF), and safety reports to IRBs
- Maintaining investigator regulatory binders across participating hospital trial sites
- Tracking Electronic Data Capture (EDC) query resolution timelines with CRO project managers
Key Opinion Leader (KOL) & Medical Advisory Board Ops
Securing endorsements from world-renowned surgeons, cardiologists, or oncologists requires meticulous relationship coordination. Your VA maps academic publishing records in PubMed, manages consulting agreements, and coordinates advisory board summits.
- Identifying top-tier academic investigators and department chairs in specialized clinical niches
- Managing physician consultant agreements, fair market value (FMV) logs, and Open Payments reporting
- Coordinating Clinical Advisory Board (CAB) meeting agendas, slide decks, and meeting minutes
Reimbursement Landscape, CPT/HCPCS & Payer Coverage
FDA clearance is useless without a path to reimbursement. Your assistant benchmarks commercial and Medicare coverage policies, tracks existing CPT/HCPCS codes, analyzes DRG hospital payment weights, and catalogs private payer medical policies.
- Compiling coverage decisions across national payers (UnitedHealthcare, Aetna, Cigna, Elevance)
- Auditing Medicare Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs)
- Assembling health economics and outcomes research (HEOR) literature for AMA CPT applications
Non-Dilutive Grant Administration & Investor VDRs
Securing non-dilutive NIH/DOD grants and venture capital requires institutional organizational rigor. Your VA coordinates federal grant milestone progress reports, formats eRA Commons submissions, and keeps your virtual data room (VDR) immaculate.
- Tracking NIH SBIR/STTR Phase I/II progress milestones and budget expenditure reports
- Managing institutional investor data rooms (DealRoom, Intralinks) with organized patent exhibits
- Reconciling capitalization tables in Carta and tracking venture debt reporting schedules
Four Steps to a Frictionless Medical Innovation Back-Office
MedTech venture founders should never spend late nights micromanaging general overseas freelancers who don't know the difference between a Class II 510(k) and a Class III PMA, or who mishandle proprietary patent claims. With SageDoer, a dedicated Project Manager oversees execution, accuracy audits, and confidentiality at zero extra charge.
Submit Venture Scope
Share your device classification (Class I, II, III), SaMD specifications, clinical stage, target regulatory pathways (FDA, EU MDR), active eQMS platform, and operational bottlenecks.
BAA & IP Protection
Your dedicated Project Manager executes mutual corporate NDAs and HIPAA Business Associate Agreements (BAAs), sets up encrypted 1Password vaults for eQMS credentials, and standardizes DHF protocols.
Dedicated Execution
Your VA maintains design control traceability in Greenlight Guru, compiles 510(k) exhibits, coordinates IRB packets, and updates investor VDRs, while your PM audits accuracy.
Pay Only for Output
Pay strictly for active productive working hours. Your Project Manager, account setup, and trained standby backup assistant coverage are 100% free with zero platform fees.
Why MedTech Founders Choose SageDoer Over Solo Freelancers
Random gig marketplaces match you with unvetted generalists who confuse 510(k) with PMA submissions, fail basic ISO 13485 audit trail standards, expose unpatented intellectual property on unsecured laptops, and disappear right before an FDA audit or audit committee milestone. SageDoer provides an institutional managed solution.
| MedTech Operations Factor | Traditional Freelance Sites |
The Clear Winner: SageDoer
|
|---|---|---|
| Dedicated Project Manager | None. Founders and chief engineers must review every document, manage daily shifts, and train basic medical terminology | Free Dedicated PM conducts daily quality audits, oversees eQMS integrity, and monitors turnaround SLAs |
| Medical Device & Regulatory Fluency | Zero. General freelancers do not understand Design Controls, ISO 14971 risk management, or 510(k) predicate crosswalks | MedTech-Trained Talent fluent in Greenlight Guru, MasterControl, FDA eSTAR, and clinical trial workflows |
| Patent IP & HIPAA Clinical Security | Severe Risk. Contractors handling unreleased patent drawings, proprietary source code, and patient trial data on home PCs | Enterprise BAA & IP Protection with encrypted password vaults (1Password), role-based access, and clean workstations |
| Platform Surcharges & Fees | 10%–20% Platform Cuts added on top of weekly contractor invoices, plus payment gateway markups | 0% Platform Fees. Flat, predictable hourly pricing with zero surprise overhead |
| Audit Crunch & Trial Sprint Reliability | High Flake Risk. Freelancers disappear right during FDA inspection prep or pivotal trial data freeze deadlines | Instant Standby Backup managed directly by your Project Manager so your regulatory pipeline never stalls |
World-Class MedTech Operations Support. Grounded Rates.
De-risk your regulatory pipeline, scale clinical trial operations, and maintain audit-defensible quality systems without taking on expensive domestic full-time payroll overhead. Dedicated Project Manager included free on every plan.
Part-Time
Ideal for seed-stage MedTech startups, SaMD creators, and early-stage innovators needing daily eQMS file maintenance, predicate device benchmarking, and grant report formatting.
Est. $560 USD / Month (4 Weeks)
- Pay only for hours of pure productive work
- Dedicated Project Manager included
- Design History File (DHF) & eQMS document tracking
- Zero setup fees, contracts or cancellation penalties
- No monthly platform memberships or surprise fees
- Predicate device research, vendor qualification & grant reporting
Full-Time
Designed for venture-backed medical device companies, clinical-stage trial operators, and commercializing device manufacturers managing heavy documentation and multi-site trials.
Est. $960 USD / Month (4 Weeks)
- Pay only for hours of pure productive work
- Dedicated Project Manager included
- Full FDA 510(k) eSTAR & EU MDR submission prep
- Zero setup fees, contracts or cancellation penalties
- No monthly platform memberships or surprise fees
- CTMS trial coordination, CPT reimbursement audits & standby backup
Trusted by Medical Device Founders, CEOs & Clinical Heads
See how healthcare technology entrepreneurs accelerate regulatory submissions, conquer audit stress, and close funding rounds with SageDoer.
"We were preparing our FDA 510(k) submission for a novel orthopedic surgical navigation system. Sifting through 400+ pages of biocompatibility test reports, electrical safety certificates, and software verification files was pulling our core engineers away from coding. Our SageDoer assistant organized our entire Greenlight Guru DHF and populated the eSTAR format without a single documentation flaw."
Dr. David Kessler, MD
Co-Founder & CEO, OrthoNav Surgical Robotics (Boston, MA)
"Managing multi-site clinical trials for our in-vitro diagnostic device was drowning our team in IRB paperwork, informed consent revisions, and investigator site check-ins. Having a dedicated SageDoer assistant oversee site compliance binders and track query resolution in Castor EDC gave our clinical team total peace of mind. The free PM oversight makes it completely hands-off."
Elena Laurent, PhD
VP of Clinical Affairs, NanoDx Biosensors (San Diego, CA)
"When we raised our $6.5M Series A, institutional healthcare VCs required an immaculate data room: freedom-to-operate (FTO) patent memos, reimbursement coding studies, supplier contracts, and animal study histology reports. Our assistant maintained our DealRoom repository and tracked all NDA downloads. We closed the round four weeks earlier than projected."
Marcus Wright
Founder & President, CardiaPulse Therapeutics (Minneapolis, MN)
"We build Class II Software as a Medical Device (SaMD) running AI on MRI scans. IEC 62304 software lifecycle documentation and cybersecurity vulnerability logs require relentless precision. SageDoer signed a comprehensive BAA, set up multi-factor 1Password vaults, and works strictly inside our Jira and MasterControl instances. At $6/hr, it’s the best hire in our company's history."
Simon Thornton, MS, BME
Chief Technology Officer, NeuroScan AI (Austin, TX)
"We were preparing our FDA 510(k) submission for a novel orthopedic surgical navigation system. Sifting through 400+ pages of biocompatibility test reports, electrical safety certificates, and software verification files was pulling our core engineers away from coding. Our SageDoer assistant organized our entire Greenlight Guru DHF and populated the eSTAR format without a single documentation flaw."
Dr. David Kessler, MD
Co-Founder & CEO, OrthoNav Surgical Robotics (Boston, MA)
"Managing multi-site clinical trials for our in-vitro diagnostic device was drowning our team in IRB paperwork, informed consent revisions, and investigator site check-ins. Having a dedicated SageDoer assistant oversee site compliance binders and track query resolution in Castor EDC gave our clinical team total peace of mind. The free PM oversight makes it completely hands-off."
Elena Laurent, PhD
VP of Clinical Affairs, NanoDx Biosensors (San Diego, CA)
Frequently Asked Questions
Everything you need to know about FDA/ISO regulatory boundaries, patent protection, eQMS platform access, and dedicated Project Manager oversight.
Accelerate Your Medical Innovation to Market
Speak directly with our healthcare technology operations team about your device classification, eQMS software stack, clinical trial milestones, and administrative bottlenecks.
Book a 30-Minute MedTech Strategy Call
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WhatsApp Founder Desk
+91 80170 67191 (WhatsApp)
Direct MedTech Inquiries Email
info@sagedoer.com
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You may also visit sagedoer.com/contact/ anytime.Submit Your MedTech Venture Scope
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