The Engagement Gap

If you've consulted in MedTech or Pharma you know the problem. Every new client is months of vendor qualification, NDAs and DPAs negotiated bilaterally, QMS onboarding to repeat. The admin overhead scales worse than the work itself. PraxisVerify fixes the engagement layer so you can do the work you're qualified for.

What You Get

  • Defined scope. Document annotation and review through the platform. Broader QA/RA work continues through your own practice.
  • One credentialing process. Verified once against the issuing bodies (IRCA, RAPS, CQI, and equivalents). Client-specific QMS training is automatic per assignment.
  • An audit-ready environment. In-browser review, no downloads, every action time-stamped.
  • Demand brought to you. Matched to assignments that fit your declared specialisms.
  • No exclusivity, no minimum commitment. Run your own practice. Take platform assignments when they suit.

How It Works for Experts

From application to first paid assignment:

  1. 1
    Apply

    Tell us your credentials, specialisms, and PI insurance details.

  2. 2
    Credential

    One-time platform credentialing, NDA, and orientation. Done once, not per client.

  3. 3
    Get matched

    Per-assignment match. Client-specific QMS training runs automatically through the platform before you access any documents.

  4. 4
    Review & get paid

    In-browser annotation, structured review comments, payment per assignment. Formal sign-off available as an add-on.

Who We're Looking For

Competency-gated, not years-of-experience-gated. Specialisms in demand at launch:

Quality systems & audit

ISO 13485 lead auditor Internal audit FDA QSR / QMSR ISO 14971 (risk) ISO 14155 (clinical) MDSAP

Regulatory submissions & review responses

EU MDR EU IVDR FDA 510(k) FDA PMA FDA De Novo FDA AI responses Notified Body deficiencies

Product safety & standards

IEC 60601 series Standards applicability Labelling & IFU EMC test plans Safety test plans

Design, software & clinical

21 CFR Part 11 / CSV Design controls DHF & tech docs SaMD / AI-ML Clinical investigation plans CEP / CER PEP / PER (IVD) PMS / PMCF / PMPF

Standalone disciplines

Biostatistics Biocompatibility Sterility Human factors

Adjacent or emerging specialism not listed? Apply anyway. Training, soft skills, and project management are not part of the launch network.

Common questions

Rates

The platform calculates a project rate from document type, size, depth of review, regulatory pathway, and turnaround. No per-engagement negotiation. You see the rate, scope, and any add-on fee triggers before you accept. Decline without penalty if it doesn't work for you.

Add-on fees apply on top of the base rate for expedited TAT inside the standard window, re-reviews following client revisions, and formal signatures.

A platform fee is deducted from the project rate; the deduction is disclosed to you at credentialing. Most assignments sit above a minimum project value disclosed at credentialing, so consultants with their own floors can self-select efficiently. No fee to apply or be credentialed.

Insurance & cyber liability

PraxisVerify carries platform-level professional indemnity (PI) cover. You carry your own PI as well. Proof of cover is part of credentialing.

Two policies, two things covered. Platform-level cover sits behind the system: matching engine, secure environment, audit trail. Your PI sits behind your professional judgement on the assignment.

Cyber risk on documents inside the secure environment sits with us; you don't need a cyber endorsement on your own PI to work on the platform. Most MedTech consultant PI policies cover platform-based annotation, but cover wording varies between insurers, so check yours and we'll flag any gaps at credentialing.

Data & AI use

Browser-based review. No installation, no downloads, no local copies, no email attachments. Documents are visible only to the assigned expert and the client who uploaded them. Every action (open, view, annotate, comment) is time-stamped, supporting 21 CFR Part 11 electronic records.

Client documents auto-delete 90 days after the end of the project, not 90 days after upload. Long or slow projects don't trigger early deletion.

Sub-processors are listed in the Data Processing Agreement, referenced from the Privacy Policy. The platform is built to ISO/IEC 27001 control families; the ISMS is operating toward formal certification.

AI-use guidance is delivered at onboarding. The load-bearing rule: client-identifying data must never enter a public AI tool.

Credentialing & invoicing

Credentialing is at individual level. Credential, NDA, audit trail, and PI cover are tied to the named expert who accepted the match.

Invoicing can route through your practice's company if that's how you operate. The commercial counterparty is whichever entity you nominate; the regulated counterparty is you. Assignments are non-transferable.

If you'd want a named associate in the network, have them apply directly. We credential individuals, not firms.

Conflict of interest

Assignments are document annotation and review only (sign-off optional). Because the scope is narrow, broader consulting or QA/RA work you do directly with the same client through your own practice is generally not in conflict. The platform engagement is bounded.

You see the client name before you accept. Where the client has asked for confidentiality on an early-stage submission, you'll see sector and jurisdiction instead. Decline without penalty if a prior relationship makes it inappropriate.

Apply your professional judgement: if you wouldn't take the review on in your own practice (competitor relationships, prior involvement with the document or its authors), flag it before accepting and we reassign.

Application & vetting

This is a selective network, not a gig marketplace. Apply with credentials, specialisms, references, and proof of PI insurance.

We verify credentials against the issuing bodies (IRCA, RAPS, CQI, Notified Body alumni networks, and equivalents). Platform onboarding covers the platform NDA, data-handling orientation, and in-browser review training. Client-specific QMS training runs automatically per assignment, before document access.

The credentialing step is a short structured submission and verification cycle, not a multi-week onboarding. The recurring cost on your side is your own PI insurance premium.

What kind of work flows through the platform

Bounded, document-anchored reviews. Clinical Evaluation Reports (CERs), Design History File (DHF) sections, 510(k) packages and FDA Additional Information (AI) responses, Notified Body deficiency responses, internal audit reports, Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) documents, technical documentation packages for EU MDR / IVDR conformity routes.

Scoped to a single document or document set, not open-ended consulting engagements.

What we don't source through the platform: full QA/RA placements, ongoing regulatory consulting retainers, training delivery, project or stakeholder management roles, inspection-readiness coaching. Valuable services, just not what the engagement model is built for.

Full terms presented at credentialing. Specific questions, raise them before applying and we'll work through them.

Apply to Join the Expert Network

Send a short email with your specialisms, credentials, and a sentence on why PraxisVerify fits where you are in your practice. We respond within one business day.

Apply as an expert

An embedded application form will replace email when the platform is publicly deployed.

Independent expert status: Experts engaged through PraxisVerify are independent contractors, not employees of PraxisVerify Limited. Expert opinions delivered through the platform are those of the individual expert. Regulatory submissions remain the responsibility of the sponsoring organisation.

Editorial Policy: Content on this website is written and reviewed by the PraxisVerify team, led by Lisa Donlon (MSc, IRCA Medical Device Principal Auditor). See our Terms of Service and Privacy Policy.