Portfolio

Four steps, one path

Every product can be booked on its own and ends in a written result your team can work with. The entry point is deliberately small: one defined question, a fixed price, no framework agreement.

Overview

The portfolio at a glance

Products 0 to 3 form a ladder: each step produces the basis for deciding on the next. The expert engagement sits across all of them and can be booked at any time.

Work is delivered mainly remotely. On-site visits at manufacturers, laboratories and partners can be arranged.
ProductPurposeDeliverableDuration
Introductory call Sharpen the question and establish whether external support is needed at all Verbal assessment and at least one concrete technical observation 45 minutes
Second opinion Have one defined technical question answered independently Written opinion with reasoning and references 2 to 3 days
Gap assessment Review a dossier, a service provider chain or a validation package in full Prioritised findings list with recommended actions 1 to 2 weeks
Continuous support Work through the findings and keep expertise permanently available Reserved weekly capacity, ongoing documentation from 6 months
Expert engagement Enter an ongoing procedure or a critical situation at short notice Written position, expert opinion or procedural support as required
In detail

The products

Introductory call

A conversation that ends with a concrete assessment — not with a proposal.

Trigger
A regulatory, analytical or clinical question has come up and its consequences cannot be judged reliably in house.
Scope
A 45-minute remote conversation. The question is sharpened, the likely effort named, and at least one substantive technical observation given that remains useful even if no engagement follows.
Result
Clarity on whether and to what extent external support makes sense.
Duration
45 minutes, free of charge and without obligation

Second opinion

One defined question, answered in writing, with reasoning that can be followed.

Trigger
A decision is pending and the internal assessment is contested or unsupported. Typically:
  • a publication contradicts your own validation data;
  • the IVDR classification of a device is disputed;
  • a method comparison study returns an unexpected result;
  • a validation plan or study protocol needs an independent read before release.
Scope
Review of the documents provided, assessed against the applicable requirements (IVDR, FDA guidance, ISO 13485, 15189 and 17025, CLSI guidelines of the EP series) and the current literature.
Deliverable
A written opinion of typically four to eight pages: assessment, reasoning, references and a clear recommendation. A follow-up call is available on request.
Duration
2 to 3 working days, normally starting within two weeks

Gap assessment

A full review of a dossier, a service provider chain or a validation package.

Trigger
A procedure is imminent or already under way and your own position is unclear. Typically:
  • first questions from the notified body on the technical documentation;
  • selection or change of the legal manufacturer;
  • a trial starting in which a laboratory result decides patient eligibility or a safety endpoint;
  • an inspection finding, a data integrity question or a change of CRO;
  • an extension of the ISO 15189 scope of accreditation or the introduction of a new platform.
Subject
Either:
  • technical documentation and performance evaluation under Annex XIII of the IVDR;
  • the chain of central laboratory and contract research organisation (CRO), including the mostly non-accredited steps before and after it — sample collection, transport, storage, result reporting and data transfer;
  • the analytical validation package, including method comparison, sample stability and sample preparation.
Deliverable
A prioritised findings list: every finding graded, referenced to the specific requirement, with its risk and a recommended action. Plus a management summary readable without a technical background, and a closing meeting.
Duration
1 to 2 weeks, at a fixed price agreed before work starts

Continuous support

Reserved weekly capacity instead of a full-time position that does not exist in house.

Trigger
Findings from an assessment need to be worked through, or a programme needs scientific and regulatory expertise over months without justifying a permanent role.
Scope
Fixed weekly capacity from ten hours, deployed as needed. Typically:
  • preparing and maintaining the performance evaluation and the technical documentation;
  • supporting communication with the notified body;
  • validation planning, method transfer and implementation into accredited routine;
  • qualification of suppliers, contract manufacturers and laboratory partners;
  • technical representation towards partners, laboratories and academic groups.
Deliverable
Ongoing work products according to the agreed programme, with a short monthly record of work performed and progress made.
Duration
Rolling, minimum term six months, terminable at four weeks' notice to month end

Expert engagement

Entering an ongoing procedure or a critical situation at short notice.

Trigger
Time pressure is the actual problem. Typically:
  • an ongoing notified body procedure with a set deadline;
  • a written position with external effect towards an authority, a partner or an investor;
  • an expert opinion on a contested technical question;
  • a technical meeting called at short notice where an independent position is needed.
Scope
Familiarisation, assessment and representation of the technical position — in writing, in the meeting or towards third parties.
Deliverable
Written position, expert opinion or procedural support as agreed.
Duration
As required, normally starting within a few working days
Matching

Which situation calls for which product

SituationMatching product
An independent publication contradicts your own validation fileSecond opinion; gap assessment if the finding is confirmed
The notified body has raised first questions on the performance evaluationGap assessment, followed by continuous support through to certification
The legal manufacturer is to be selected or changedGap assessment with continuous support through to contract and transfer
A trial is starting in which a laboratory result decides patient eligibilityGap assessment of the chain of central laboratory and CRO
An inspection finding concerns the sample pathways ahead of the central laboratoryExpert engagement, then gap assessment of the remaining studies
A new method is to be implemented into accredited routineContinuous support; second opinion where the question is narrow
A deadline is running and a defensible technical position is missingExpert engagement
Who this is for

Whom this portfolio is built for

IVD manufacturers in the IVDR transition

Devices certified under the old Directive 98/79/EC (IVDD), particularly class B and C, that now require a performance evaluation under Annex XIII of the IVDR.

Rights holders without their own manufacturing

The test is made by a third party; there is no legal manufacturer and no quality management system of your own.

Pharmaceutical and biotech sponsors

Trials whose eligibility criteria depend on laboratory results, with a chain of central laboratory and contract research organisation (CRO) that nobody reviews internally.

Laboratory groups and reference laboratories

An extension of the ISO 15189 scope of accreditation, a new mass spectrometry platform, or transferring a specialist method into accredited routine.

Fees on request Fixed prices agreed before work starts Mainly remote delivery NDA before any documents change hands Conflicts of interest disclosed

Start with the introductory call.

45 minutes, free of charge and without obligation. After it you will know whether one of the four steps fits your question — and which one.

Get in touch