Strengthening our implant‑grade QA system under ISO 13485

Over the past quarter we’ve been tightening the “boring parts” that actually make OEM programs work: lot traceability, in‑process controls, and a cleaner COA workflow. This update summarizes what changed, why it matters, and how to request the right document package.

Below is a practical summary for customers who are qualifying materials or running an OEM program. If you need a specific document package, tell us your stage (evaluation vs production) and your target spec.

What we improved (and why)

• Lot traceability: clearer links between incoming raw inputs, in‑process batches, and finished lots.
• In‑process checkpoints: defined controls at the points that most influence particle size distribution (PSD), moisture, and phase stability.
• COA workflow: public pages keep typical values for quick evaluation; production lots can be supported by a full COA package when requested.

If any of the points above maps to your current bottleneck, we can suggest a grade and the minimum documentation set that keeps the project moving.

What this means for OEMs

• Faster onboarding: easier supplier-file reviews when your team asks for traceability and documentation scope up front.
• Less back-and-forth: you can specify “typical values for evaluation” vs “lot-specific full COA for production”.
• Better comparability: consistent internal checkpoints reduce avoidable lot-to-lot drift.

If any of the points above maps to your current bottleneck, we can suggest a grade and the minimum documentation set that keeps the project moving.

How to request the right documentation package

• Tell us the product(s), target PSD range, and the intended use (R&D screening vs pilot/production).
• Indicate your documentation scope: COA only, or COA + trace elements + additional supporting docs as applicable.
• If you have a template/spec, send it—alignment is faster than guessing.

If any of the points above maps to your current bottleneck, we can suggest a grade and the minimum documentation set that keeps the project moving.

Related products

• Calcium phosphate family (α‑TCP, β‑TCP, HA, TTCP/OCP, DCPA/DCPD)
• 45S5 bioactive glass (micro / microspheres / nano)
• CPC powder‑kit and porous scaffold systems

If any of the points above maps to your current bottleneck, we can suggest a grade and the minimum documentation set that keeps the project moving.

Quick request template

Product(s):
Target PSD range + method:
Application (R&D / pilot / production):
Quantity + timeline:
Documentation needed (typical / full COA / trace elements / other):

Contact: info@kannrybio.com