Quality & regulatory

Systems, not slogans

For suppliers and investors, this page says more about what kind of company we are than the product page does. Here is what actually runs and which standards it follows.

01 — Quality management system

ISO 13485 implementation underway

Company processes are built on the medical device QMS framework, covering:

Document and record control
Design and development control, including inputs, verification and validation
Corrective and preventive action (CAPA)
Risk management per ISO 14971

02 — Supplier management

Outsourcing treated as a controlled process

Every external relationship runs through a formal process rather than quotations alone:

A user requirement specification is written before any RFQ goes out
Supplier qualification, including confirming that the ISO 13485 certificate scope actually covers the item
Critical component suppliers under change-notification control
Where subassemblies are outsourced, Fonming remains legal manufacturer of the finished kit

03 — Inspection & process control

Measure first, then control

We establish our own measurement baseline for critical materials rather than accepting datasheets:

Incoming inspection SOP and pressure drop measurement for porous filter media
Statistical process control with accept/reject limits
Sampling inspection per ISO 2859-1
100 % leak testing on finished goods — not sampled

04 — Sterilization & biocompatibility

Designed from the hardest-to-sterilize point

Sterilization approach and validation plan for the single-use consumable set:

EO sterilization validation per ISO 11135
Sterilant residual testing per ISO 10993-7
Biocompatibility evaluation per the ISO 10993 series
Risk assessment completed for the hardest-to-sterilize location in the assembly

05 — Regulatory affairs

Regulation as a design input

The regulatory pathway has to be settled during design, or late changes will eat the project. Our approach is to obtain classification and attribute determination from the authority first, then freeze the design.

Pre-submission classification inquiry to TFDA to confirm classification and applicable pathway
Comparison against existing domestic approvals for comparable products to build the substantial equivalence argument
Where split certification is used, confirming existing domestic precedent first
Reviewing US FDA, Japan, Korea MFDS and China NMPA classification practice in preparation for international filing
No claim of clinical effect in any company material or on this site before approval

Please note

Some of the systems and validation activities described on this page are in progress or planned rather than completed certifications. To confirm the current status of a specific item or request documentation, write to qa@fonming.com.tw.