How to Choose a CGM SKD Manufacturer: A Pre-Contract Audit Checklist
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Choosing a CGM SKD manufacturer is a different decision from choosing a device supplier. With finished goods, the worst case is a bad batch and a switched supplier. With SKD, you are building a local production capability and taking on a registration in your own market — so the manufacturer's documentation, training and long-term supply behaviour become part of your regulatory and commercial risk.
This checklist is the one we would run through before recommending any partner, and the one we expect a serious buyer to run on us. (New to the model? Read what CGM SKD is first; if you are still choosing between models, see the OEM vs SKD vs CKD comparison.)
1. Does the manufacturer own the engineering, or resell it?
Ask who fabricates the sensor electrodes, who formulates the membrane chemistry, and who performs calibration. A partner that assembles third-party sensors into a housing cannot improve yield, cannot support accuracy claims with their own data, and cannot help you when your authority asks technical questions.
Look for: in-house sensor manufacturing, a traceable calibration process, and performance data they generated themselves.
2. Can they define the kit precisely, in writing?
"The kit includes the sensor and the transmitter" is not a specification. You want a component-level bill of materials, the assembly sequence, the acceptance criteria for each step, and a clear statement of what is excluded.
Look for: a kit configuration document, an assembly SOP, and a per-step quality checkpoint list.
3. What documentation will they supply for your registration?
This is where SKD projects stall most often. Your local registration depends on technical documents the manufacturer must provide — performance verification reports, quality management certification, design and manufacturing information, and in most markets clinical or analytical performance evidence.
Look for: a named documentation package list, samples of the actual documents (not templates), and a commitment that they will answer your authority's questions after submission — our own SKD model page lists what we hand over at each stage.
4. Is the quality system real, and certified?
ISO 13485 certification is the baseline expectation for a medical device partner. Ask to see the certificate and its scope — whether the sensor, the kit preparation and the outgoing quality process are all inside the certified scope.
Look for: certificate with scope, last audit date, and how out-of-spec batches are handled and communicated.
5. What does training actually cover?
A kit that is easy to assemble is not the same as a team that can assemble it consistently at volume. Training should cover cleanroom protocol, the assembly sequence, in-process checks, and root-cause handling when something fails.
Look for: on-site or remote enablement sessions, a written training curriculum, refresher training terms, and documentation you can use to train new hires later.
6. How is supply continuity protected?
You are committing to a market, a registration and a brand. If component supply stops, your product stops — and your registration does not transfer to another kit overnight.
Look for: capacity figures, lead times, buffer/stock policy, commitment on component change notification, and what happens contractually if they exit the product line.
7. What are the assembly prerequisites — stated honestly?
A partner that tells you your facility is fine as-is is not helping you. The realistic prerequisites are a cleanroom at Class 10,000 (ISO 8) or higher for sensor housing assembly, an ISO 13485 or equivalent quality system, and trained personnel.
Look for: a documented readiness assessment of your facility before contract signature, not after.
8. Is territory structure clear, and is it written down?
Most SKD manufacturers structure partnerships with regional exclusivity — commonly one partner per country. You need to know whether competing importers can be appointed in your market afterwards, and on what conditions.
Look for: exclusivity terms by territory, performance conditions attached to exclusivity, and renewal/termination logic.
9. Is there a software layer behind the hardware?
A CGM without a data experience is a component, not a product. Your patients need a working application; your clinicians may need a portal. In SKD, that software should be available to you via API or SDK, with clear support terms.
Look for: patient app availability, API/SDK access terms, data residency answers, and whether the app can be branded and localised for your market.
Scoring your shortlist
Give each candidate a mark against the nine items above. The pattern matters more than the total:
- Documentation and quality items (2, 3, 4) are pass/fail. Without them your registration cannot proceed.
- Training and prerequisites (5, 7) are schedule items. They affect how long enablement takes, and they are solvable.
- Supply, territory and software (6, 8, 9) are strategy items. They determine whether the partnership still works in year three.
The six questions that end most sales conversations early
If you only have one meeting, ask these:
- What exactly is included in the SKD kit?
- Which certifications do you hold, and what is their scope?
- Can you provide assembly training and the SOPs behind it?
- What documentation do you supply for my local registration?
- Can we start with a pilot order?
- Do you limit the number of SKD partners in a single country?
A supplier who answers all six with documents is worth a second meeting.
Frequently asked questions
Do I need prior medical device manufacturing experience? No. Basic cleanroom protocol knowledge is enough to begin; assembly training and SOPs are provided by the manufacturer. What you do need is a route to market and a valid local device licence, or a plan for one.
How long does enablement take? It depends on your market's registration timeline more than on assembly. Kit assembly itself is the shorter part — typically mastered during enablement and refined with volume.
Is a pilot order realistic? Yes, and you should insist on one. A pilot validates both the product and your process before you commit to annual volume.
Evaluating CGM SKD partners? Talk to our team → — we will walk through this checklist against your market, and you can evaluate a sample kit firsthand.
