Productised Regulatory Writing · Fixed-Fee Engagements

Regulatory writing
at fixed fees.

Senior, single-author CER, FDA 510(k), Pre-Submission, IVDR PER and PMPF documentation for medtech and IVD SMEs — scoped per deliverable, priced from a published "from" rate, delivered in 4–10 weeks.

For companies that need a specific regulatory document rather than a full operational engagement. Operational engagements (fractional COO, advisory, project leadership) are scoped per–client based on time commitment and complexity, and discussed in an initial 30–minute call. See the main NuAge Technologies site for those services.

01

The offerings

FDA · Entry product
FDA Pre-Submission (Q-Sub)
From $5,500 AUD ex GST
Drafted Pre-Sub package for FDA written feedback or meeting. 3–6 focused questions, predicate analysis where applicable, PreSTAR or eCopy delivery. The lowest-risk way to test FDA pathway assumptions before committing to a full 510(k). FDA charges no user fee for Pre-Subs.
3-week cycle Single revision round
View one-page offering →
EU MDR · Medical Devices
Clinical Evaluation Report (CER)
From $14,000 AUD ex GST
CER compliant with MDR Article 61 and MEDDEV 2.7/1 Rev 4. Includes literature search, evidence appraisal, GSPR conformity matrix, benefit–risk analysis, and conclusion. Delivered in editable Word and signed PDF for direct insertion into your technical documentation.
4–6 week cycle Single revision round
View CER sample →
FDA · Medical Devices
FDA 510(k) Submission
From $22,000 AUD ex GST
Complete 510(k) submission package via PreSTAR. Includes predicate analysis, substantial equivalence rationale, indications for use, device description, performance testing summary, and labelling section. Delivered submission-ready for client to upload via the CDRH Customer Collaboration Portal.
8–12 week cycle Single revision round
View 510(k) sample →
EU IVDR · In Vitro Diagnostics
IVDR Performance Evaluation Report (PER)
From $25,000 AUD ex GST
PER compliant with IVDR Article 56 and Annex XIII Part A, structured around the three pillars of scientific validity, analytical performance, and clinical performance. Includes the Performance Evaluation Plan and synthesis of client–supplied evidence. SVR/APR/CPR sub–reports and PMPF documentation are scoped separately.
8–10 week cycle Single revision round
View PER sample →
EU IVDR · Recurring
PMPF Plan + Annual Evaluation Reports
Plan from $5,500 · Bundle from $9,500 · Annual Report $5,500/yr
Post–Market Performance Follow–up documentation under IVDR Annex XIII Part B. PMPF Plan as a one–off, then PMPF Evaluation Reports annually (required at least yearly for Class C and D IVDs per Article 56(6)). The Plan + Year 1 Report bundle establishes the surveillance system for the IVDR life cycle; subsequent annual Reports keep your CE Mark renewal evidence current.
3–5 week cycle Recurring engagement
View PMPF offering →
Considering hiring instead
Weighing whether to hire a senior Regulatory Affairs Manager rather than engage a fractional writer? We've done the math. A one-page decision framework with Australian salary data, total loaded cost, break-even submission volume, and three factors often missed in the hire decision.
Read the framework →
02

How engagements work

01
Discovery call
30–minute call to confirm device, regulatory pathway, target jurisdiction and milestone. Honest assessment of whether and how NuAge can help.
02
Statement of Work
Fixed–fee SoW with explicit scope, exclusions, deliverables and milestones. Issued within one week of the discovery call where there is a clear fit.
03
Drafting and review
Single–author drafting against client–supplied inputs. Draft delivered for your review, then one revision round before final delivery.
04
Final delivery
Submission–ready document in editable Word and signed PDF. 30 days of post–delivery email query support included.
03

Why a productised model

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Senior single–author qualityEvery document is drafted personally by Wayne Jensen PhD — the same author across your CER, PER and 510(k) work. No junior handoff after the SoW. The regulatory narrative stays consistent across documents and across years.
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Fixed fees, transparent scope"From" pricing published openly. Each engagement scoped to a specific deliverable with explicit inclusions, exclusions and assumptions. No hourly billing, no surprise variations, no retainer.
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Cross–jurisdictional consistencyFDA, MDR, IVDR, TGA experience under a single author. Your 510(k) for the US market and CER for the EU market read consistently because the same person wrote them — reviewers notice.
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Clear scope boundariesNuAge does not act as Person Responsible for Regulatory Compliance (MDR/IVDR Article 15), does not submit on your behalf, and does not absorb open–ended scope. What you sign for is what you get.
Need more than a document
If your need is operational rather than document–specific — fractional COO leadership, R&D programme oversight, capital–raise readiness, ISO 13485 implementation — the main NuAge Technologies practice covers that.
Visit the main site →
04

Start a conversation

A 30–minute discovery call is the fastest way to determine whether one of these productised offerings fits your need. No commitment, no pitch — a practical conversation about your device, regulatory pathway, and timing.

✉ wayne@nuage-technologies.com ☎ +61 400 898 890 in linkedin.com/in/wayne-a-jensen

What to expect

When you reach out
  • A response within one business day
  • An initial 30–minute call to confirm regulatory pathway and target deliverable
  • An honest assessment of whether and how NuAge can help — no overselling
  • If there is a fit, a fixed–fee Statement of Work within one week
  • If there is not, a candid recommendation of what kind of support you actually need