Medical Device Contract Manufacturing
Responsive, quality-focused. Committed to 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 2009, FDA registered — Laguna Hills, CA.
Our Philosophy
Do it right the first time.
A&M Biomedical has built a reputation as a responsive, quality-focused, contract manufacturer committed to assisting customers of all sizes realize their manufacturing goals. As a small organization with a talented, dedicated team, A&M can respond quickly to our clients’ evolving requirements and help them reduce inefficiencies and maximize results.
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.
More than a critical supplier, we see ourselves as a manufacturing partner to our customers. A&M is an extension of their companies and we encourage customer involvement, presence, and oversight at every stage of production.
Responsibility is our reputation
End-to-end medical device contract manufacturing.
Assembly & Production
- Class 7 cleanroom assembly
- Non-cleanroom electro-mechanical assembly
- Precision manual assembly for complex devices
- Prototype, R&D & pilot builds
- Pilot to high-volume (up to 150,000+ units/mo)
Packaging, Sterilization & Fulfillment
- Packaging, labeling & kitting
- Transport to/from sterilization partners
- Sterilization release coordination
- Distribution & order fulfillment
- Inventory management & tracking
Quality & Process Controls
- ISO 13485 QMS (certified since 2009)
- IQ/OQ/PQ process validation & documentation
- Structured change control, full traceability
- Supplier qualification & ongoing auditing
- Receiving inspection & incoming QC
“When we needed to quickly launch a contract manufacturer for a biological product to supplement internal production capacity, we looked at several companies and A&M Biomedical stood out for its people and flexibility.”
David AmudaMaterials Manager · Advanced Sterilization Products (Johnson & Johnson)
“A&M has consistently delivered the highest level of quality with lean manual assembly and in-process inspections, in addition to rapidly responding to our changing production demand.”
John PoseyStaff Operations Engineer · Advanced Sterilization Products
“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 reliably delivered on their promises — timing, cost, and quality — and has treated us like a partner, even when we were a small-volume customer.”
David LalorVP of Operations, Regulatory Affairs & QA · Vertos Medical
“A&M Biomedical has always built our manufacturing lots with care and efficiency. They strictly follow ISO 13485 requirements, and communication between our company and A&M has always been great.”
Jay Lenker, Ph.D.Founder, President & CEO · Indian Wells Medical
“A&M’s experienced team of medical device professionals — an environment that created an open exchange of information and a ‘partnership’ philosophy — were instrumental in enabling us to complete the development of our device.”
Tony VioleDirector of Product Development & Operations · Dental Imaging
Specialties built on decades of process knowledge.
Cardiovascular
Respiratory
Ophthalmic
Surgical / Lumbar
Brachytherapy
Dental
Biological Indicators
Electromechanical
Incontinence
From 300 units a month to Fortune 500 acquisition.
In 2015, Vertos selected A&M to manufacture their minimally invasive lumbar surgical kit. We scaled from ~300 to 4,000+ units/month — roughly thirteenfold, across two device generations, without missing a delivery. When Stryker acquired Vertos in 2024, A&M’s track record was a factor in the deal.
13x
Peak Scale-Up
2
10+
Year Partnership
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 Operations, Regulatory Affairs & QA, Vertos
Cianna → Merit Medical
Quality that survives transitions
Our partnership with Cianna continued seamlessly after Merit’s acquisition. Merit kept 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 outperformed it — preventing backorders.
Quality Culture
A Shared Commitment to Quality
Melissa Fontes
Owner & CEO · A&M BioMedical
Success in any business requires the involvement of many different people inside and outside of your organization. The key to achieving and sustaining long-term success with your product comes down to the type of people you choose to work with and ensuring they share your commitment to quality.
The team that runs A&M Biomedical has come together through our work at various medical device companies. We all came to A&M Biomedical as a result of our shared team-approach and our commitment to uncompromising quality. We know the importance of ensuring the safety and efficacy of each and every product manufactured and distributed to the end user. We understand the challenges medical device companies face with ever-evolving regulatory requirements and international standards.
When you choose A&M Biomedical to manufacture your medical devices, in addition to our experience and expertise, you get the benefit of working with a group of people who will care about the quality of your product as much as you do — and the assurance of knowing that when it comes to quality, compromise is not part of our process.
Melissa Fontes
Owner & CEO · A&M BioMedical
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 on request
- Direct CEO access on every program