In medical device OEM, “sampling” should not mean random trial builds. A strong sampling service is a structured workflow designed to reach a stable specification quickly—then scale with controlled processes.
What a good sampling service includes
1) Feasibility review
Before building anything, the OEM should confirm:
Critical requirements and target market assumptions
Packaging constraints (label sizes, languages, compliance considerations)
Risk items and open questions that could block scaling
2) A sampling plan (deliverable-based)
A sampling plan should clearly state:
What will be built (BOM-level clarity)
What will be tested/inspected (acceptance criteria)
What decisions will be made after sampling (go/no-go gates)
3) Pilot run definition
A pilot run is not “a bigger sample.” It is where you:
Lock process steps that affect quality
Confirm packaging and labeling controls
Confirm stable yields and predictable lead time
Why ISO 13485 matters for sampling
ISO 13485 is useful even at sampling stage because it enforces:
Document control (revision history)
Nonconformance handling (what happens when sample fails)
Traceability (what material lot created which sample)
This structure reduces hidden risk later when you scale.
How to reduce sampling iterations (save weeks)
Provide clear target market and labeling expectations early
Share reference samples or competitor benchmark constraints
Agree acceptance criteria before the OEM builds
Keep a single source of truth for spec revisions
The sampling → pilot → scale workflow
Stage 1: Prototype/Sample Build
Goal: Prove feasibility and lock basic specs
Deliverables:
Physical samples (typically 10-50 units)
Initial BOM and process notes
Packaging mockup or prototype
Timeline: 2-4 weeks (depending on complexity)
Stage 2: Pilot Run
Goal: Validate process stability and packaging controls
Deliverables:
Pilot batch (typically 500-2000 units)
Locked process documentation
Final packaging and labeling approval
Quality inspection records
Timeline: 4-6 weeks
Stage 3: Mass Production
Goal: Scale with controlled quality and predictable lead time
Requirements:
Approved master batch record
Change control process in place
Supplier qualification complete
Packaging artwork locked and versioned
Common mistakes that delay scaling
1) Unclear acceptance criteria
If you don’t define “pass/fail” upfront, every sample becomes a negotiation.
2) Changing specs during pilot run
Pilot run is for validation, not redesign. Lock specs before pilot.
3) No packaging plan
Packaging and labeling often take longer than the product itself. Plan early.
4) Skipping traceability setup
If you can’t trace material lots in pilot run, you’ll have chaos in mass production.
Questions to ask your OEM before sampling
What information do you need to prepare a sampling plan?
What is your typical sampling timeline and deliverables?
How do you handle spec changes during sampling?
What defines a successful pilot run?
What documentation do you provide at each stage?
If you want a fast sampling → pilot run path, send a brief requirements pack (market, product type, packaging, volume, timeline). A certified OEM can reply with feasibility, sampling milestones, and production readiness steps.