Medical Device Contract Manufacturer

Medical Device Contract Manufacturing

Responsive, quality-focused.

Contract manufacturer committed to assisting partners of all sizes.

30+ years helping medtech teams scale from first article to Fortune 500 acquisition. Direct CEO access on every program. ISO 13485 certified since 2016, FDA registered, Laguna Hills, CA.

Our Philosophy

Do it right the first time.

We utilize a hands-on, flexible approach to project management involving our entire management team to bring our customers’ projects to fruition and ensure our customers’ quality objectives are achieved. The A&M team brings more than 30 years of medical device, manufacturing, and QMS experience to our customer projects.

What We Do

End-to-end medical device contract manufacturing.

From prototype and pilot builds through high-volume production, packaging, sterilization support, and fulfillment — one partner for the full device lifecycle.

Assembly & Production

Class 7 / Class 8 cleanroom assembly
Non-cleanroom electro-mechanical assembly
Precision manual assembly for complex devices
Prototype and R&D builds
Pilot through high-volume production (150–150,000+ units/mo)

Packaging, Sterilization & Fulfillment

Medical device packaging, labeling, and kitting
Transportation to and from sterilization partners
Sterilization release coordination
Distribution and order fulfillment
Inventory management and tracking

Quality & Process Controls

ISO 13485 certified quality management system
Process validation (IQ/OQ/PQ) and documentation
Structured change control with full traceability
Supplier qualification and ongoing auditing
Receiving inspection and incoming QC

Built for Established Medtech

Compliance & quality control. One manufacturing partner.

A FDA registered and ISO 13485 Certified medical device manufacturer of sterile and non-sterile devices, A&M Biomedical utilizes a Quality Management System to continuously improve our processes and to keep our customers in compliance.

Reliable supply. Predictable delivery.

When your production has to be there month after month, you need a partner whose numbers don't move. A&M Biomedical utilizes a Quality Management System to continuously improve our processes and to keep our customers in compliance.

For each project, we provide assessment in the following areas:

Review and redline product specifications for completeness and effectiveness
Assist in identification of appropriate sampling plans for receiving, in-process, and final inspections
Create MPs, QPs, DTs and MTs to establish customer's DMR
Create protocols and perform installation, operational, and performance qualifications, as required

With 30 plus years of in-house experience, A&M Biomedical is able to assist our customers in all aspects of production documentation and compliance.

Validated. Repeatable. Documented.

Your process needs to hold. A&M runs full IQ/OQ/PQ process validation, structured change control, and Class 7/8 cleanroom assembly. Our commitment to quality and reliability is why clients turn to us and keep returning to us for their manufacturing needs.

Class 7 / Class 8 cleanroom assembly (ISO 14644)
IQ/OQ/PQ process validation protocols & execution documentation
Structured change control with full traceability
Precision manual & electro-mechanical assembly for complex devices
Receiving inspection + incoming QC on every lot

Full service, end to end.

A&M BioMedical provides full-service contract manufacturing exclusively to medical device customers. We work in HEPA-filtered facilities operating under an ISO 13485 quality management system, employ a team of highly trained operators, and use our QMS to ensure your quality standards are maintained end to end.

Our team has a diverse background in medical devices and delivers quality-focused manufacturing for manual assembly processes. We accommodate any size production — from pilot runs to high-volume manufacturing — and provide turnkey services when our customers need them.

HEPA-filtered facilities under ISO 13485 QMS with highly trained operators
Any size production — from pilot runs to 150,000+ units/month
Engineering support via our network: prototype tooling, production molds, manufacturing equipment, and custom production tooling
Sterilization & validation coordinated with established supplier relationships — all quality controls and documentation maintained

Case Study
Vertos Medical → Stryker

From 150 units per month to Fortune 500 acquisition.

In 2015, Vertos Medical selected A&M BioMedical to manufacture their minimally invasive lumbar surgical kit. Starting at 300 units per month, we scaled production to a peak of 4,000+ units per month — roughly thirteenfold growth across two device generations — in a planned program aligned with clinical adoption. Full IQ/OQ/PQ process validation. In-house manufacturing lines. V1 to V2 product transition managed without missing a delivery.

When Stryker acquired Vertos in September 2024, A&M’s track record was a factor in the deal. They visited multiple times to understand how we executed the program. Stryker chose to keep production at A&M for two more years post-acquisition.

13x

Peak Scale-Up

2 Device Generations

10+

Year Partnership

A&M has consistently exceeded my expectations in many ways. Vertos has found A&M to be extremely compliant with FDA and ISO standards. A&M has treated us like a partner — allowing full access, promptly notifying us of any issues, and being fully committed to our success, even when we were a small volume customer.

— David Lalor · VP of Operations, Regulatory Affairs & QA

More Long-Term Partnerships

Three more medtech teams who stayed.

Cianna → Merit Medical

Quality That Survives Transitions

Our partnership with Cianna Medical continued seamlessly after acquisition by Merit Medical. Given our manufacturing experience and in-depth product knowledge, Merit chose to keep production at A&M — over four years post-acquisition.

ASP / Johnson & Johnson

Manual Precision Beats Automation

When ASP’s automated equipment couldn’t keep up with biological indicator demand, A&M’s manual assembly process outperformed the automated alternative — keeping pace with demand and preventing backorders.

Indian Wells Medical

Complex Device Transfer

A&M managed the manufacturing transfer of the Steerable Transeptal Needle for catheterized cardiac procedures — refining the assembly process and establishing full QMS compliance for this high-precision device.

Device Breadth

Medical specialties. Decades of accumulated process knowledge.

From minimally invasive surgical kits to diagnostic biological indicators, A&M has manufactured across the full spectrum of medical devices.

CEO on every call

Meet the CEO

When you call A&M, you talk to me.

Most medical device contract manufacturers will route you through an account manager, a sales engineer, and a project coordinator before you ever reach someone who can make a decision.

We work differently. Because we’re a smaller, focused, women-owned organization, you get direct access to the CEO and the engineering team actually building your product. Fast decisions. Honest answers. Real partnership.

That’s the only way I know how to build the kind of trust that lasts through an acquisition — and the only way I’d want to do it.

Melissa Fontes

Owner & CEO · A&M BioMedical

Start a Conversation

Ready to see if A&M is the right fit?

Tell us about your device and your timeline. We’ll schedule a consultation to discuss how our ISO 13485 certified manufacturing services can support your program.

Free manufacturing assessment
Response within 24 hours
No obligation consultation
NDA available upon request
Direct CEO access on every program