How to Choose a Medical Device OEM: ISO 13485 & GMP Checklist

Selecting an OEM partner is a risk decision. A good manufacturer protects your timeline, brand, and compliance posture. A weak manufacturer creates delays, rework, and unpredictable outcomes.

Below is a checklist you can use when sourcing an OEM partner—especially if your target markets require strong quality expectations.

ISO 13485 certification

Ask for:

- Certification scope (what sites and activities are covered) - Audit cadence and certification body details - Internal audit and management review cadence (high-level summary is enough)

GMP readiness

Depending on product category and market expectations:

- Hygiene controls, controlled procedures, training records - Complaint handling and recall readiness (process-level discussion)

Process control

Ask:

- What are the critical-to-quality steps? - How do they prevent mix-ups and labeling errors? - How do they handle deviations and nonconformities?

Traceability

Ask:

- Batch/lot traceability approach - Material receiving and supplier qualification workflow - Record retention approach

Many OEM relationships fail at the handoff from "sample" to "scale." Ask:

- Do they have a structured sampling plan template? - What defines a successful pilot run? - How do they lock specs and manage revisions?

Ask the OEM to show sample templates (redacted is fine):

- Inspection records and acceptance criteria - Batch records / production reports - Packaging and labeling control (artwork versioning, approvals, revision history)

This is where long-term partnerships win:

- Engineering change workflow and approvals - How they notify customers about changes - Lead time impacts and risk assessment process

- "We can do anything" without asking about target market and specs - No clear answer on labeling/packaging control - Vague timelines that shift every week - No structured approach to sampling → pilot → scale

To get a fast, meaningful response, include:

- Product category and target market - Desired packaging format - Estimated volume and timeline expectations - Any critical requirements (label languages, labeling constraints, etc.)

---

If you want a faster supplier evaluation, request a feasibility review with a short requirements pack and ask for MOQ + lead time + sampling milestones in writing.