Services
Everything on this page is evaluation work: reading the evidence behind a product and putting it in a form a buyer can act on. We do not hold inventory, arrange shipping, or take a margin on any product we evaluate. The fee is for the diligence, not the goods.
Product and technical evaluation
Every engagement starts with a defined product category and a defined set of candidate manufacturers, either supplied by the client or built by us from public registries, trade data, and manufacturer outreach. For each candidate, we work through the technical file the manufacturer can produce: performance data, verification and validation reports, bench and (where applicable) clinical study data, instructions for use, and service documentation.
What we are looking for differs by product type, and we treat that difference as the core of the work rather than a footnote. For an in-vitro diagnostic, the evaluation centers on analytical performance: sensitivity and specificity against a defined reference method, positive and negative predictive value in the intended use population, precision and reproducibility across lots and operators, and the conditions under which the manufacturer's own validation study was run. A sensitivity figure quoted without the reference standard, the sample size, or the prevalence of the condition in the study population is not evidence, it is a number, and we flag the difference plainly in our reports.
For capital equipment and durable devices, the evaluation centers on a different set of questions: expected service life under the duty cycle the buyer actually intends, the availability and lead time for spare parts and consumables, whether the manufacturer supports the model with local or regional service technicians or requires the unit to be shipped back to the country of manufacture for repair, calibration requirements and intervals, and the practical footprint, power, and environmental requirements the equipment will impose on the buyer's facility. A device with excellent bench performance and no realistic path to local servicing is, in practice, a liability three years into ownership, and we say so.
For consumables and reagents, we look closely at lot-to-lot consistency data, shelf life and storage requirements, and whether the manufacturer's supply chain can support the volumes the buyer actually needs without repeated stockouts.
Manufacturer and quality-system review
A strong product from a manufacturer with an immature quality system is a risk that tends to surface after the purchase order is signed, in the form of inconsistent lots, unexplained design changes, or a slow and evasive response to a field issue. We review what a manufacturer can show us about how it designs, verifies, and controls its products: whether it operates a documented quality management system consistent with recognized frameworks such as ISO 13485, how it manages design changes and corrective action, and what its history looks like with respect to recalls, field safety notices, and regulatory findings in the markets where it already sells.
We are candid that a desk-based review has real limits. It can establish whether a manufacturer's documentation is coherent, current, and internally consistent, and whether its public regulatory history raises anything a buyer should ask about directly. It cannot substitute for a buyer's own on-site audit where the scale of the purchase justifies one. Where a client wants that deeper layer of assurance, we help define what an on-site or third-party audit should cover, based on what our desk review has already surfaced.
Regulatory pathway and classification mapping
Medical devices and diagnostics are classified differently depending on the jurisdiction and the intended use, and the classification determines the evidence a manufacturer was required to generate before it could sell the product at all. A device that is low-risk and lightly regulated in its country of manufacture may sit in a higher risk class elsewhere, with a correspondingly thinner evidence file behind it than a buyer would assume from the classification alone. We map each candidate product against the classification and approval pathway in its country of origin (for example, FDA device class and clearance or approval route in the United States, or the risk class and conformity assessment route under the EU Medical Device Regulation or In Vitro Diagnostic Regulation), and compare that against what the buyer's own market will require for import or registration.
This mapping exercise routinely surfaces the gap between "approved somewhere" and "approvable here": a product cleared in one jurisdiction under a pathway that assumed a predicate device or a specific intended use may need additional data, additional labeling, or a different classification argument entirely to clear a different market. We flag that gap early, before it becomes a surprise during the buyer's own registration process.
Comparative shortlisting
Once the evidence is in hand, we compare candidates against a set of criteria agreed with the client at the start of the engagement, weighted to reflect what actually matters for that buyer's use case. The output is a written comparison, not a spreadsheet of adjectives: where a claim is well supported, where it is thin, and where two products that look identical on a datasheet diverge once the underlying study design is examined.
| Evaluation axis | What it captures | Typical evidence reviewed |
|---|---|---|
| Analytical or clinical performance | Whether the product does what it claims, under what conditions | Validation studies, reference method comparisons, precision data |
| Manufacturing and quality maturity | Whether output is likely to stay consistent lot to lot, unit to unit | QMS documentation, design history, recall and complaint history |
| Regulatory standing | What approval pathway the product actually followed, and where | Clearance or approval letters, classification rationale, labeling |
| Serviceability and total cost of ownership | What it costs to keep the product running over its working life | Service network, spare parts lead time, consumable pricing and availability |
| Supply reliability | Whether the manufacturer can actually deliver at the volumes required | Production capacity, export history, lead times quoted by references |
Documentation support for market registration
Getting a product onto a shortlist is not the same as getting it registered for import and sale in the buyer's own market, and many buyers underestimate how much of that second task depends on documentation the manufacturer already has, but has not yet organized into a usable package. We help clients identify and request the specific documents their own regulator will expect: the manufacturer's free sale certificate or equivalent, the Declaration of Conformity, test and validation reports, instructions for use in the required language, ISO 13485 certification and scope, and, where relevant, a letter of authorization naming the buyer or its local representative.
We do not file registrations or act as a buyer's regulatory agent of record; that role sits with the buyer or a locally licensed representative. What we provide is the technical groundwork: knowing which documents to ask a manufacturer for, recognizing when what has been provided is incomplete or inconsistent with the classification claimed, and flagging gaps before they surface as regulator queries months into the process.
Category monitoring
Some clients engage us once, for a specific purchasing decision. Others ask us to keep watching a product category over time: new manufacturers entering the field, updated clinical evidence on existing products, recalls or field safety notices affecting products already on a client's approved list, and shifts in regulatory pathway that could affect future imports. Monitoring engagements are scoped around a defined category and cadence, and the output is a short update rather than a full re-evaluation, escalated to a full review only when something material changes.