Consulting
The gap between the equipment you own and the standard you are held to.
Accreditation readiness, validation and qualification, regulatory support, laboratory and facility design, and programme framework design.
Advice that makes you compliant, efficient and fundable.
What it covers
12- 01
ISO 15189 & SLIPTA readiness
Gap assessment, QMS documentation, SOP development, internal audit, competency assessment, EQA enrolment, mock assessment, through to accreditation.
- 02
Equipment qualification (IQ/OQ/PQ)
Installation, operational and performance qualification with documentation packs formatted for assessment.
- 03
Method validation & verification
Verification of methods on new platforms and correlation against existing methods.
- 04
Temperature mapping & cold chain validation
Mapping and validation of refrigerators, freezers, cold rooms and transport containers, with documented reports.
- 05
Biosafety cabinet certification
Annual certification of Class I, II and III cabinets and laminar flow — a mandatory recurring requirement that is very poorly served regionally.
- 06
Rwanda FDA regulatory support
Registration dossier preparation and submission, classification advice, notification pathway management.
- 07
Technical audits & condition surveys
Full inventory and condition assessment of an equipment estate with a costed remediation and replacement plan.
- 08
Laboratory & facility design
Layout, sample flow, containment zoning, bench and utility planning; fit-out; hospital department design.
- 09
Tender specification writing
Writing the technical specifications a facility or ministry will tender against.
- 10
Capital replacement planning
Multi-year replacement schedules mapped to budget cycles.
- 11
Digital transformation
LIS and HIS selection, workflow redesign, deployment planning and change management.
- 12
Programme framework design
Linkage-to-care pathways, consent, counselling and safeguarding frameworks for screening programmes.
How it runs
Consulting — from standard to evidence
Why adopt it
You will recognise yourself here, or you will not.
You have an accreditation assessment coming and no evidence trail
You are about to build or refurbish a laboratory and the plan was drawn by an architect without laboratory input
You are a manufacturer who needs Rwanda FDA registration and has no local route
Your biosafety cabinets have never been certified, or you cannot find the certificate
You are writing a tender and need specifications that will actually get you what you want
You are designing a screening programme that touches minors or stigma-sensitive conditions
The process, with timing
- 011 meeting, no charge
Scoping conversation
What standard you are being held to, and where you think the gaps are.
- 021–3 days on site
Gap assessment or audit
On-site assessment against the standard, with findings ranked by risk.
- 031–2 weeks
Costed plan
What to fix, in what order, with effort and cost against each item.
- 04Per engagement
Delivery
Documentation, validation, mapping, certification or design work as scoped.
- 05Before assessment
Verification
Internal audit or mock assessment before the real one.
- 06Annual
Recurring items
Biosafety certification, temperature mapping and calibration recur on an interval — moved onto a schedule.
Proof, not promises — and the questions we actually get asked.
A procurement officer does not debug a claim, they form an impression. So every proof point here is one you can verify.
No. Consulting is sold separately and we support laboratories running other suppliers' instruments.
No, and be careful of anyone who says otherwise. Accreditation depends on sustained management commitment. We can guarantee an honest gap assessment and a realistic plan.
We are here next month, and the month after. And we can execute the remediation, not just describe it.
What stands behind every configuration
Engineer profiles — names, photographs, manufacturer certifications
Manufacturer authorisation letters, published as documents
Rwanda FDA registration certificates for every product we supply
Published case studies follow as soon as customers approve them — we would rather show this than an empty "coming soon".