01 / 07
Surgical Instruments & Handhelds
Grips, housings, and structural components where ergonomics, clinical durability, and cosmetic consistency all carry the spec.
Medical & Life Sciences
CLEANROOM MOLDED.
AUDIT READY.
An ISO 9001-certified manufacturer supporting the medical device industry with validated manufacturing processes, traceability, and controlled quality systems. Class 8 cleanroom molding in both of our U.S. facilities, so your program carries a second source from its first shot.
ISO 9001-Certified
Both facilities, independently audited
Two Class 8 Cleanrooms
Pittsfield, MA & Ormond Beach, FL
IQ/OQ/PQ Support
PPAP and First Article on programs that require it
Toner Plastics Group
U.S. manufacturing, under one group
01 · The Range
Built for the device classes where variation is not an option.
From intricate geometries to high-volume disposables, each of these categories carries the same demands: documented processes, controlled materials, and parts that perform exactly as validated.
02 / 07
Drug Delivery Components
Actuation housings, sliding mechanisms, and precision components engineered for controlled motion and repeatable engagement across the device lifecycle.
03 / 07
Diagnostics & Cartridges
Fluidic components and cartridge bodies where dimensional stability and material purity decide whether the assay works.
04 / 07
Single-Use Disposables
High-volume cleanroom molding with the batch documentation and material control disposables demand.
05 / 07
Respiratory & Infusion
Protective housings, flow components, and material-controlled parts that provide impact protection and environmental shielding.
06 / 07
Wearable Devices
Insert overmolded housings and skin-adjacent components in biocompatible material pairs.
07 / 07
If you can spec it,
we can build it.
Device not listed? Start with a conversation, not an upload. Drawings change hands after the NDA does.
Talk to an engineer →Molded Here
02 · Materials
Material expertise for medical applications.
Material selection decides performance, safety, and compliance before the first shot. We help identify, source, and validate the right resin for the design, and we push back when the drawing calls for the wrong one.
01 / 03
Biocompatible Resins
USP Class VI and ISO 10993-evaluated resins for patient-contact applications, with material rationale documented for your submission file.
Documentation
Lot-controlled material certs on request
02 / 03
Sterilization-Compatible Plastics
Materials qualified for EtO, gamma, autoclave, and e-beam sterilization, selected against your method before tooling is cut.
Methods
EtO · Gamma · Autoclave · E-beam
03 / 03
High-Durability & Specialty Polymers
Engineering-grade resins for fatigue, chemical, and thermal demands across the device lifecycle.
Guidance
Not sure where to start? Talk materials with an engineer.
03 · Quality & Traceability
Your submission does not wait on our documentation.
The quality system, the methods behind it, and a written statement of where our responsibility ends.
01 / 04
Validation Support
IQ, OQ, and PQ execution support, PPAP, and First Article on programs that require it. We document our part. Your regulatory approval stays yours.
Scope confirmed in writing before the program starts
02 / 04
Traceability
Lot control and batch records on every regulated run, with part marking and serialization where a program requires it.
Lot control · Batch records · Part marking
03 / 04
Change Control
The process you validated is the process that runs. Changes move through documented review, and you sign off where the program requires it.
Documented review before any process change
04 / 04
Audit-Ready Documentation
Certificates, batch records, and process documentation pulled and organized when an audit is scheduled.
Full sourcing disclosure during qualification, under NDA
"ISO 9001-certified manufacturer supporting the medical device industry with validated manufacturing processes, traceability, and controlled quality systems."
Transfer With Confidence
Bring your tool
home.
Moving a medical program from another molder or offshore supplier? Our seven-point transfer inspection documents the tool's condition, identifies repair needs, and builds a qualified production path without losing the history your quality system depends on.
Explore the Transfer Program7-point
Inspection of every transferred tool
Day 1–5
Teardown, measurement, and documentation
Run-ready
Validation before the tool enters production
04 · Continuity
Your second source is built in.
Two Class 8 cleanrooms, eleven hundred miles apart, governed by one ISO 9001 quality system. Qualify the system once, and the continuity plan your risk file requires is already standing, staffed, and certified.
2 cleanrooms
ISO Class 8 in Pittsfield, MA and Ormond Beach, FL. Identical classification, identical documentation.
1 quality system
The same ISO 9001-certified standard governs every regulated run, in either facility.
2 states
Geographic separation your business continuity assessment can actually cite.
05 · Proven At Scale
When demand surged,
we scaled.
During the COVID-19 pandemic, we scaled production of critical respiratory supply chain components on compressed timelines, inside the same quality system that governs every regulated run.
When demand surged, we scaled, quickly, reliably, and without compromising quality.
06 · The Program
Design to production.
One accountable partner.
1
Step 01
Concept & DFM Review
Gate locations, resin choice, and wall sections challenged by the engineer who will run the part.
2
Step 02
Bridge Tooling
Incepta Tooling steel in 4 to 6 weeks for validation builds in production-intent material.
3
Step 03
Tooling Qualification
Production tooling qualified in our own toolroom and maintained there for its production life.
4
Step 04
Validated Production
IQ/OQ/PQ support, then documented process control on every run, in either cleanroom.
5
Step 05
Lifecycle Support
Change control, batch documentation, and continuity through the life of the device.
07 · Why Modern Mold & Tool
Why medical teams stay.
01
Pushback Before Steel
If we cannot engage on your gate locations and resin choice in the first conversation, you should not hire us. We can, and we will, while changes are still cheap.
02
NDA First, Drawings Second
Device IP never moves through an open upload form. The NDA executes, then the drawings change hands, then the engineering conversation starts.
03
The Process You Validated Is the Process That Runs
Change control discipline means no supplier-driven drift after qualification, and no surprises during your next audit.
04
A Second Source in the Floor Plan
Two Class 8 cleanrooms under one quality system. Supply continuity is a fact of the architecture, not a paragraph in a proposal.
Free GuideMedical Injection Molding Guide
Free Industry Guide
The Definitive Guide to Medical Injection Molding
Cleanroom molding, validation strategy, material selection, and regulatory-ready documentation for medical device teams. Everything you need to de-risk your next program.
Ready When You Are
Start a program conversation.
Tell us the device class, the volumes, and where the program stands. An engineer responds, the NDA executes, and then the real conversation starts.
Or call directly: 413-443-1192
- ISO 9001:2015 Certified
- In-House Toolroom
- Made in the USA