Expertise

Vision inspection and traceability solutions for medical devices

OUR CORE EXPERTISE

A true understanding of device identification complexities

Perfected over nearly three decades, our core expertise resides in the development and integration of innovative vision inspection, verification and traceability technologies for regulation compliance. 

Our finely tuned process for successful project management and integration of complex, custom-designed systems, gives us a unique ability to tailor our current solutions to our customers. Integrating these solutions in a timely and efficient manner is key in order to meet the regulatory requirements deadlines.

These key points, along with our deep understanding of the challenges you are facing to ensure regulation compliance, make us the ultimate partner for your UDI implementation project.

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Project Management Process

A finely tuned machine.

UDI regulations come with implementation deadlines. Step-by-step management of the development and integration process, based on sound and adapted technological choices, is key in meeting your timeline.

Optel designs solutions based on its proprietary products or best-in-class, third-party components and assumes first-line responsibility for the integration process. We have all the in-house expertise and experience required to provide personalized guidance, take on the entire project and guarantee its success. With cross-functional specialists at every phase of the project, we work with you throughout the entire development and integration process ─ overseen every step of the way by capable, tech-savvy project managers.

Take a detailed look at each of the 11 steps of our time-proven project management process.

 

1. Pre-Project Engineering

Inspection and UDI solutions are highly complex and require experts, even in the first stages of the sales process. Our dedicated sales team is specialized in medical devices, with in-depth knowledge of packaging lines, IT and the supply chain. For every project, we work with your team to carefully define the project requirements and offer the best solution for your application.

2. Project Management

We consider every project unique, and we make sure every customer receives the highest-quality solution. All projects are driven by an experienced Project Manager (PM) that follows a well-established and documented process based on the GAMP/PMMI guidelines. The Project Manager’s target is to optimize the quality triangle, meeting all requirements ─ on-time and on-budget. The use of the project planning module in our SAP-B1 ERP system provides us with a real-time view of the entire project status, timeline and capability.

3. Vision Engineering

From simple package inspection to the most sophisticated packaging-line UDI solution, the key is to have an outstanding optical setup and vision algorithm.

Our Project Managers and Vision Engineers work together to carefully select the most appropriate illumination, camera requirements, vision tools and parameters to achieve the most efficient solution.

4. Mechanical Engineering

Optel delivers robust systems, designed to last as long as your packaging line equipment. Our Mechanical Designers use stainless steel and aluminum and follow GMP guidelines for all enclosures, brackets and ejectors. Based on Project Manager and customer feedback, our solutions are well-engineered, rugged, easy to adjust and simple to set up.

5. SOFTWARE ENGINEERING

Software is at the heart of all of our applications. Whether it’s managing multi-level serialized information, exchanging data with EPCIS, SCADA and packaging-line devices, or designing operator-friendly user interfaces, our large team of Software Engineers is behind the success of our solutions. Together with our Product Managers, who regularly initiate new features and product developments, Software Engineers have made Optel Vision the most innovative company in the industry.

6. Manufacturing

Our manufacturing operations enable us to offer fast turn-around time and quick delivery. Every critical part is serialized and logged into the system’s history log file, allowing us to track every component. The use of SAP-B1 ERP provides us with a real-time view of the entire manufacturing process and parts availability, worldwide.

7. Validation Specialist

With over 25 years of close collaboration with global customers, we understand the importance of documentation. Our experienced Validation Specialists and Technical Writers ensure that your operation manual is adapted to your specific solution. Manuals are provided with a full set of documents covering qualification, installation and operation (IQ and OQ), as part of our standard validation documentation.

8. Quality Control

Our experts in the Quality Control Department use both generic and specific test plans to test the entire solution. The Quality Control Technician performs a pre-validation of the system prior to shipping, ensuring that the integration process will go smoothly and will be completed in a timely manner.

9. Integration

Located all over the world, our team of highly skilled Field Technicians travel to your plant to install, test and validate your new equipment. For more complex integration projects, the Project Manager is also on-site, assisting the technicians to ensure that the overall integration and start-up is well-synchronized and that everything runs smoothly. Optel Field Technicians receive comprehensive training from the Optel Education Center, which ensures that they utilize the best installation practices for all our equipment.

10. Support

We understand the importance of a quick response time and good direct support for lines that are running and generating revenue.

With our adjustable Service Plans, you get the best ROI.

Our plans guarantee access to our Service Managers 24/7 to support and assist you. Only one phone call to make, no other parties are involved. All requests are processed promptly and we will involve all the necessary experts to solve your problem. We use our SAP-B1 service module to monitor all of the open issues and ensure that appropriate support is provided in a timely manner.

11. Education Center

The Optel Education Center was created to provide specialized training and development not only to employees, but to customers as well. For each project delivered, we provide on-site training and related documentation, which allows you to operate our system with confidence. Our training program is rigorously monitored through our quality and continuous improvement processes so that every deployed solution is covered. All employees are trained, certified, and kept up to date, thus ensuring the best-quality service.