TUTAMEN MEDICAL

Medical manufacturing from component to finished device

Tutamen Medical supports regulated medical product companies with component manufacturing, cleanroom assembly, final assembly and test, electrode production, and production transfer for active and non-active medical devices.

We help customers reduce supplier fragmentation and move from product file, prototype, or transfer requirement into documented, scalable production.

Component Manufacturing FATP Orthopedic Assembly Electrode Production Regulation Support

ISO 9001

Manufacturing quality-system foundation.

ISO 13485

Medical device quality-system support.

FDA-registered

Manufacturing establishment.

Cleanroom

Production capability.

Anti-static

Assembly room.

510(k)-cleared

TENS/NMES device, self-adhesive electrodes, and more.

WHY NOW

Medical Supply Chains Are Being Rebuilt

Medical device companies are under pressure to shorten supply chains, reduce supplier fragmentation, improve production control, and move faster from regulated product files into scalable manufacturing.

But many products still rely on separate vendors for components, electrodes, assembly, packaging, testing, and documentation support. Tutamen Medical was built for that gap.

Fragmented Suppliers

Multiple vendors across components, consumables, assembly, test, and packaging.

Transfer Risk

Regulated products are difficult to move without documentation, inspection, and process control.

Nearshore Demand

North American customers need shorter, more controlled production paths.

Active Device Complexity

Wearable and controller-based products require electronics-aware assembly and functional test.

WHO WE SERVE

Built For the Companies Shipping Regulated Devices

Medical Device Brands

Active and non-active device programmes requiring controlled assembly, inspection, and production support.

Orthopedic & Rehab Companies

Brace, support, frame, soft-good, and component assembly programmes.

DME & Therapeutic Product Teams

Electrodes, consumables, wearable assemblies, recovery products, and programme-specific manufacturing support.

Supplier Transfer Programmes

Customers moving production from legacy suppliers, offshore supply chains, or fragmented component networks into a controlled manufacturing platform.

HOW WE WORK

From Requirements to Production, Here's How It Works

01

Share Your Requirements

Send us the product family, drawings, target volume, regulatory status, production location, cleanroom needs, test requirements, and transfer timeline.
02

Review Manufacturing Scope

We assess component needs, assembly steps, documentation, inspection points, test requirements, packaging, labeling, and programme-specific quality obligations.
03

Build and Validate the Process

We create the production workflow, work instructions, inspection plan, FATP process, and transfer path required for the programme.
04

Scale to Controlled Production

Once the process is locked, the programme moves into controlled production with defined inspection, test, documentation, packaging, and release procedures.

Component manufacturing · Cleanroom assembly · FATP · Electrode production · Orthopedic assembly · Transfer manufacturing

CAPABILITIES

Four Manufacturing Pillars, One Production Partner

Component Manufacturing

Precision plastic, metal, soft-good, and electromechanical components for medical and therapeutic products — from injection-molded parts and stamped components to wires, fittings, frames, and production-ready subassemblies.

FATP for Active Medical Devices

Final assembly, test, packaging, and production transfer support for active, controller-based, wearable, and customer-specific assemblies under approved work instructions and quality agreements.

Braces and Non-Active Devices

Assembly and subassembly for orthopedic braces, supports, soft goods, frames, and non-active medical products, supported by component production, packaging, inspection, and documentation.

Electrode and Skin-Contact Consumables

Production of self-adhesive electrodes and related skin-contact consumables, with wire assemblies, private-label programmes, packaging, inspection, and regulatory documentation support.

THE FULL STACK

From Skin Contact to Finished Therapy System

Many medical products depend on the interface between the patient, the material, the electronics, and the finished assembly. Tutamen Medical supports that full path — from skin-contact consumables and electrodes through active assemblies, packaging, labeling support, validation coordination, and production transfer.

01

Materials

Adhesive, conductive media, skin-contact materials
02

Interfaces

Electrodes, pads, patient-contact assemblies
03

Devices

Controllers, active assemblies, wearable systems
04

Production

FATP, packaging, inspection, transfer

QUALITY & PRODUCTION

Controlled Assembly, Test, and Documentation

Tutamen Medical supports controlled production environments and documentation workflows for regulated medical products — from incoming inspection and in-process control through functional test, packaging, labeling, and outgoing inspection.

Production Controls

Incoming inspection
In-process control
Functional test and final assembly
Packaging and labeling support

Documentation & Release Support

Outgoing inspection
IFU and documentation support
Production transfer support
Programme-specific quality agreements

NEARSHORE MANUFACTURING

Nearshore Medical Manufacturing for North American Programmes

Tutamen Medical supports customers who need to launch, re-source, private-label, or transfer regulated products into a controlled production environment. The Mexico platform is supported by engineering, sourcing, and production resources across the Tutamen network.

Launch

Prototype or pilot build into production.

Re-source

Move supply out of fragmented or long-lead chains.

Private Label

Support packaging, labeling, inspection, and extensions.

Scale

Move from validated process to controlled volume.