We offer the following to assist you with your regulatory approval process:
- cGMP declaration and cGMP and compliance to 21CFR8201 on Data Sheets and each Certificates of Conformance
- Separate Certificate of Sterilization for each lot (for sterile Overwraps only)
- Change notifications prior to relevant changes
Customized solutions can be provided to meet special compliance needs.
Please contact our Regulatory Support Team for all your regulatory requests & questions:
Phone: +49 761 88 88 9 – 302
121CFR820: Quality System Regulations for Medical Devices of the Code of Federal Regulations of the United States