Can I purchase PCL’s pre-validated packaging if I use a different contract manufacturer (CM) for my packaging?
Only clients who use PCL/PCM as their contract packager can purchase our prevalidated CompliancePack packaging.
Can PCL help with protocol authorship?
PCL can act as extra fire power for your existing team and author your protocols.
Can PCL manage packaging validation?
Yes, PCL performs complete packaging validation and testing in accordance with ISO 11607.
Do you offer sterile packaging?
Yes, PCL provides sterile barrier packaging in a Class 7 cleanroom, including tray and pouch sealing. We also offer pre-validated sterile packaging options.
How do you maintain lot traceability?
Following our ISO 13485 certified Quality Management System, all CPack materials are assigned an internal lot number during the receiving process. The original supplier lot number is kept on file and the internal lot number is tracked to ensure that traceability is maintained from the packaging supplier all the way to the finished good.
How much faster can I launch my device to market with PCL’s pre-validated packaging, CompliancePack?
Clients of PCM can shave months off their project timeline when they use CompliancePack. A typical timeline for CPack + PCL contract packaging launch if clients have samples ready is three to four months.
Is CPack compliant to any required standards or certifications?
CPack processes (e.g. sealing validation, aging) were conducted following the requirements specified in ISO 11607. All testing was executed per the laboratory divisions ISO 17025 accreditation.
What devices can PCL package?
We package a wide range of Class I, II, and III medical devices across multiple specialties. Both sterile and non-sterile products are supported.
What is a typical timeline for launching a device?
Timelines vary, but pre-validated packaging can significantly shorten the overall schedule.
What is medical device contract packaging?
Medical device contract packaging is outsourcing the final packaging, labeling, and documentation of your device to a qualified partner. PCL provides turnkey kitting, assembly, sealing, and finishing so devices are ready for market.
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