The lifecycle
| Step | What happens | What you receive |
|---|---|---|
| 1 · Scoping call | Thirty minutes, complimentary. Device, intended purpose, markets, stage, constraints, what already exists. | A written scope within three working days: first deliverable, inputs, output, exclusions, timeline, fee. |
| 2 · Applicability assessment | Qualification and classification in each target market; the regulations, standards (by edition) and guidance that apply; representation needs. | An applicability matrix the rest of the engagement is built on. |
| 3 · Gap assessment | Existing documentation and systems reviewed against the applicability matrix. Findings graded and prioritised the way an auditor would grade them. | A findings report with severity, evidence reference and a closure action per finding. |
| 4 · Roadmap | Sequence, owners, evidence still to be generated, laboratory or clinical work to coordinate, timeline. | A plan you can put in front of management and a notified body. |
| 5 · Development | Documents, procedures and assessments drafted. Every statement traced to a requirement or a source. | Controlled drafts, issued under document control. |
| 6 · Technical review and traceability verification | A second-pass review of every deliverable by the consultant, including AI-assisted drafts; the trace from each statement to its source checked. Where a project engages a separately named qualified professional, independent peer review is recorded as well. | A review record stating which of the two applied. |
| 7 · Implementation support | Training, record set-up, coordination with laboratories, notified bodies and agents. | Working procedures and records, not shelf documents. |
| 8 · Submission and audit readiness | Mock review, question-and-answer rehearsal, final completeness check. | A readiness note listing residual open points, if any, before anything is submitted. |
| 9 · Post-implementation monitoring | Regulatory-change watch for the engagement's frameworks; PMS cadence set up; hand-over notes. | A change log for the six months after delivery. |
What traceability means here
Traceability is a working method, not a word on a brochure. In practice it means three things.
First, every requirement that applies to the device has a row: the general safety and performance requirement, the ISO 13485 clause, the FDA provision, the CDSCO rule. Second, every row names the method by which it is addressed and the document that holds the evidence, by identifier and section. Third, the trace runs both ways: open the test report and it names the requirement it satisfies; open the requirement and it names the report.
The matrix on the home page is an excerpt, redacted, from an issued technical file. Rows that are not yet closed are shown as not yet closed. A matrix with every cell green before the work is done is a sign that someone has filled the matrix in rather than built it.
Technical review
Two different things are often called "independent review". They are distinguished here.
Consultant review is a second pass by the same consultant, separated in time from drafting, working from the source documents rather than the draft, and checking that every statement traces. It applies to every deliverable, including anything drafted with the help of retrieval tools.
Independent peer review is a review by a separately identified, qualified professional who did not write the deliverable. It applies when a project engages one — a clinical specialist on a clinical evaluation, an IVD scientist on a performance evaluation plan — and the deliverable's review record names them.
The review record states which of the two applied. A deliverable is never described as independently reviewed when only the first applied.
Document control
Every deliverable carries an identifier in the form AC-client-type-nn, a version, an issue date and the reviewer's name. Superseded versions are retained under the retention schedule in the privacy notice. Comments are returned against the version they were made on, and changes between versions are listed at the front of the next issue.
Regulatory change during an engagement
Standards are revised and guidance is reissued while work is in progress. The applicability matrix records the edition and revision of each reference at the start, and step nine watches those references for the six months after delivery. If an edition changes mid-engagement, the change, its effective date and its impact on the deliverable are recorded and discussed before the work continues on the new basis. The website's own content follows the same rule; every regulatory page carries its review date and status.