SOLUTIONS FOR MEDICAL DEVICES

Ensuring patient safety through technology

You’ve invested time, money and energy into quality assurance while doing your best to keep costs low and productivity high. But is your quality system doing its best for you?

Manual packaging and handling procedures, outdated data-management systems and the constant risk of human error can too easily compromise the quality and integrity of medical devices, putting patient health and safety at risk.

As the industry moves toward more stringently controlled, connected medical devices, OPTEL’s innovative, turnkey vision inspection and digital traceability solutions can help get you there―with minimal disruption to precious productivity time.

LET’S TAKE ON YOUR CHALLENGES TOGETHER

Machine Vision - Icon: Increase quality assurance and avoid false rejects

Quality assurance and false rejects

On average, one company per year sees a 10 percent drop in share price after a single, major quality event, and the risk of long-term reputational damage is real.*

Machine Vision - Icon: Reduce Recalls

Recall reduction and management

Non-routine quality events such as recalls cost the industry an average of up to $5 billion per year, yet many manufacturers still rely on monolithic systems that actually slow their ability to track and manage recalls.*

Machine Vision - Icon: Trace your devices up to the patient

Tracking devices up to the patient

In the event of a recall, tracking medical devices up to the patient is critical, yet some manufacturers don’t even have a warehouse management system (WMS) in place to tell them where their product is in the supply chain.**

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COMPLYING WITH UDI REGULATIONS

In the wake of media reports about medical device recalls, defects and government oversight, many regulatory bodies are now drafting or enacting tougher controls over medical devices. Failure to comply is not an option.

OUR SOLUTIONS: VISION INSPECTION

Machine Vision - Thumbnail: Product and Direct Marking Inspection

Product and direct marking inspection

Verify direct-marked or embossed codes, and inspect product integrity and characteristics such as dimensions, shape and color.

Machine Vision - Thumbnail: Packaging and Seal Integrity Inspection

Packaging and seal inspection

Inspect the integrity of packaging and seals by detecting contaminants for better quality control.

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Kit and tray inspection

In addition to detecting component presence, our systems use metrology to detect millimetric differences in the general attributes of the devices contained in kits and trays.

Machine Vision - Thumbnail: Labeling and Printing Inspection

Labeling and printing inspection

Inspect printing on packaging materials, including flexible web, Tyvek, paper, foil, pouches and more. Detect label presence and characteristics, artwork and variable data, barcodes and grading to comply with UDI regulations.

Learn about vision inspection

OUR SOLUTIONS: TRACEABILITY

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Visibility along the supply chain

Medical device companies often collect and consume data as static documents, but data becomes valuable only when it is transformed into intelligence that can be leveraged to drive improved quality and streamline processes.**

Learn about traceability

Get in touch with our experts to discuss your challenges and learn how OPTEL can support you.

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Our differentiators

Why OPTEL?

We guarantee your project’s success, thanks to our finely tuned project management process and our ability to integrate custom-designed solutions―regardless of complexity.

With hundreds of successful projects in more than 35 countries, we’ve gained the ability to create and adapt custom solutions to your reality.

We have the expertise to understand your needs in a holistic way, taking into consideration the different configurations and local conditions of your production and packaging lines, compliance with quality standards and regulations, as well as tight deadlines and other constraints.

Let OPTEL be your partner to bring your inspection and traceability projects to fruition. We’re ready to take on your greatest challenges.

What you get when you partner with OPTEL:

  • 30 years of proven expertise
  • Turnkey solutions that are adaptable, agile and scalable
  • Easy integration with any system/machine, regardless of vendor
  • Start-to-finish project assistance
  • Personalized technical services
  • Data reporting
  • IQ/OQ validation documentation
  • World-class technical support
  • A partner that is technology-oriented and socially responsible

Machine Vision - Icon: UDI regulations

Learn about UDI regulations

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Machine Vision - Icon: Resources

Consult our resources

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Machine Vision - Icon: Vision Inspection

Learn about vision inspection

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Machine Vision - Icon: Traceability

Learn about Traceability

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Our featured products

PHARMAPROOF™

This automated, serialization-ready vision system inspects the presence and characteristics of components in kits and trays, as well as data on labels, large webs, direct-marked products, seals and other packaging.

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HD PrintSafe™

HD PrintSafe™ is an all-in-one, drop-on-demand printing and inspection solution for web and label printing.

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Machine Vision - Image of the HDPrintSafe with CIS (Contact Image Sensor)

CIS PrintSafe™

CIS PrintSafe™ is a 100% web inspection solution using contact image sensor (CIS) inspection technology and an innovative, flexible automated vision system that you can install on your existing printer.

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Machine Vision - Image of the CIS (Contact Image Sensor)

Verify Platform

Whether your priority is serialization, traceability, authentication, brand protection or customer engagement, OPTEL’s flexible Verify Platform is the engine to protect and grow your brand and boost your bottom line.

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TrackSafe™

Whether you require serialization on products, packaging lines or labelers, our TrackSafe™ products can help you optimize your overall serialization process while meeting current and future regulatory requirements.

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Machine Vision - Image of the TrackSafe Software for traceability