ARE YOUR MEDICAL DEVICES READY FOR THE MARKET?

Before your terminally sterilized medical devices can be launched, they must be enclosed in packaging that not only preserves their sterility but also holds up under scrutiny from regulatory bodies.

Do you have a robust validation program? Are you confident in your compliance with ISO 11607-2? If you’re navigating these complex requirements, PRO-TECH is here to help.

Choosing PRO-TECH means opting for a partner who is deeply familiar with the nuances of ISO 11607-2 and committed to ensuring your packaging processes are up to standard. Here’s why we are the preferred choice for medical device companies:

• Expertise in Packaging Standards: We have extensive experience with ISO 11607-2 and understand the intricacies of its requirements. Our team ensures your packaging process is compliant and efficient.
• Comprehensive Validation Methods: We use certified testing processes to validate sealing and packaging processes, ensuring consistent compliance with ISO 11607-2 standards.
• Custom Compliance Solutions: Every medical device is unique, and our services are tailored to meet the specific needs of your products and packaging requirements.

Comprehensive Documentation: We provide detailed validation documentation required for regulatory submissions and audits, making the compliance process smoother and more transparent.