Overcome Small Batch Challenges
Medical device manufacturers rely on Packaging Compliance Labs for turnkey, ISO 13485–certified contract packaging services that reduce risk and accelerate market readiness. Our contract packaging team manages every step—from kitting and assembly to sterile barrier packaging, labeling, sealing, and documentation—ensuring your device meets regulatory requirements and arrives shelf-ready.
The planning, prep, and manufacturing are done.
Packaging is the final step. We've got you covered.
Pre-Validated Packaging
CompliancePack™ (CPack) is an expedited sterile packaging solution developed by Packaging Compliance Labs (PCL), designed specifically to meet ISO 11607 requirements. Leveraging CPack enables medical device manufacturers to significantly accelerate their device launch timelines, potentially saving months in development and validation. Available in both tray and pouch configurations, CPack offers flexibility to suit diverse packaging needs, ensuring compliance without compromising speed-to-market.
Sterile Product Contract Packaging
All medical device packaging and sealing operations are conducted within our ISO Class 7 cleanroom. Services include light assembly, labeling, and sterile packaging sealing.
Sterilization Validation & Sterile Product Management
Achieve sterilization while we manage the process for you. We partner with third-party sterilization providers to ensure the correct sterilizing agent and the characterized exposure required to achieve sterility. Methods include Gamma, EO, and EBeam.
Learn More About Sterilization Validation & Sterile Product Management
Medical Device Precision Cleaning
PCL helps determine if your medical device needs a formal cleaning process before packaging and sterilization, and offers precision cleaning solutions like parts washing and ultrasonic cleaning to support validation and routine cleaning.
We’ll oversee packaging from start to finish and get those small batches to market.
Patient Safety First
Become the Expert
Go the Extra Mile
Why Medical Device Companies Choose PCL
The advantages we offer:
ISO 13485 certified
Class 7 Cleanroom
Experience with Class I, II, and III devices
Sterile packaging expertise
Integrated packaging validation and testing (ISO 11607)
No minimum volume requirements
Fast turnaround and responsive project management
We don't just engineer and test packaging.
We DO packaging. And we let you celebrate another satisfying launch.
Who We Support
- Early-stage medical device startups
- OEMs needing to dual source
- Orthopedic, cardiovascular, neuro, diagnostics, wound care, etc.
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