Optical Devices + Assemblies
We have over 35 years acknowledged expertise in manufacturing:
- Rigid endoscopes and assemblies
- Flexible endoscopes
- Autoclavable hermetic cells and subassemblies
- Autoclavable cameras
- Camera couplers
Access Optics partners with medical OEMs to manufacture precision optical components, sub-assemblies, and complete devices. Although we can⎯and do⎯fabricate precision optics in volume, our core value lies in our engineering and contract-manufacturing services. Our particular specialties include sophisticated medical imaging and surgical visualization devices.
We are certified to the design and development provision of ISO 13485:2003. This enables us to work with you to convert your innovative designs to practical, manufacturable devices. With decades of aggregate experience, our optical design team can take your idea from concept to prototype, and forward to real-world production of devices that consistently meet specifications and deliver improved patient outcomes.
Our design services are just the start. You can streamline operations by outsourcing your subassemblies to us. Based on our thorough regulatory compliance and documentation, you can have full confidence that every unit you receive will be ready for use. If you want to go one step further, we can build your entire product, delivering complete devices tested, approved, and private labeled. From start to finish, we tenaciously protect your intellectual property. We recognize that it is your highest value, which makes protecting it our highest value. Our quality strategy has been implemented throughout our operations as part of what we call the AO Way [link to values page]. As a result, we’ve earned “dock-to-stock” status with an array of tier-one OEMs in the medical-device industry.
To win regulatory approval, you need a design history file (DHF) that documents every step of the process from prototyping through production. As part of our ISO 13485 certification, we’ve established procedures to deliver meticulous documentation formatted specifically to support DHF requirements. We not only streamline your design and manufacturing, we take most of the effort out of the completion of your DHF.
At its heart, medical device manufacturing is about risk management. Let us take risk out of the equation for you, as we have done for a host of other customers. We build devices using ISO-certified processes for traceability and lot control. As a US FDA-registered manufacturer, our operations support the strictest regulatory transparency requirements. If process failure mode effects analysis (PFMEA) is part of your vocabulary, you can be comfortable knowing that it’s a solid part of ours, as well.
Our production facility is certified to ISO9001:2003 and ISO 13485:2003. Learn more about our quality-assurance program here.