MAC holds ISO 13485:2016 certification and builds to IPC/WHMA-A-620 Class 3 — the same standard we apply to aerospace and defense. When failures are not acceptable, this is the standard you need.
The Standards
Certifications only matter if your supplier understands what they require — and has built their operation around them.
ISO 13485 is the quality management standard for medical device manufacturing. Unlike ISO 9001, it adds specific requirements for regulated medical applications: process and documentation controls, risk management, post-market surveillance process support, and enhanced traceability requirements.
Class 3 is the highest tier of the IPC/WHMA-A-620 workmanship standard for wire harness and cable assemblies. It applies to high-reliability applications where equipment downtime, failure, or unreliability is unacceptable — including medical, aerospace, and defense.
Medical device regulations require complete traceability throughout the manufacturing process. MAC's AS9100D and ISO 13485 quality systems provide documentation from raw material receipt through final inspection and shipment.
IPC J-STD covers soldering processes and materials. Our technicians are certified to J-STD requirements, and we have on-site J-STD trainers who maintain that certification internally.
What We Build
Why MAC for Medical
Audited and current. The quality management standard for medical device manufacturing — not an aspiration, a certification.
IPC/WHMA-A-620 Class 3 on every medical assembly. The same standard we apply to aerospace and defense. On-site trainers certify our own people.
Earpiece overmold, PCB overmold, connector overmold — all done at MAC. No sub-tier risk, no lost quality control.
From raw material receipt to shipment. Documentation that supports your regulatory submissions and quality records.
In-line and end-of-line electrical testing on every assembly. In medical applications, sampling isn't good enough. We test every unit.
Built in Vandalia, OH. No offshore sub-tiers on your medical assemblies. Supply chain you can audit and verify.
The MAC Advantage
Medical device OEMs need a contract manufacturer with the quality system to match their regulatory requirements. MAC has built that system — and maintained it for years.
Quick Reference
| ISO 13485 | Certified (2016) |
| AS9100D | Certified |
| ISO 9001 | Certified (2015) |
| Workmanship | IPC/WHMA-A-620 Class 3 |
| IPC Trainers | On-site |
| Testing | Every unit; end-of-line |
| Location | Vandalia, OH 45377 |
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