SIGMA’s international quality and GMP certifications, including ones from the U.S. FDA and ISO (ISO 13485 and ISO 17025), ensure our management control systems are aligned to fulfill customers’ needs at the highest levels, guaranteed.

Design Verification and Changes

Our products are designed in Taiwan, with all process management carried out in accordance with the design control stipulations of the U.S. FDA, Taiwan FDA, and ISO 13485.

Materials Verification

All our products are manufactured with the same high-quality materials that ensure the most consistent performance for sealing and opening functionality under the most-demanding healthcare environments. Safety goes hand in hand with functionality. In that respect, we use lead-free and medically safe inks (in compliance with the requirements of ISO 10993). Moreover, the selection and control of medical sterilization packaging materials is carried out in accordance with EN 868 packaging requirements.

Product Validation

In conducting tests, we adhere to TAF laboratory (ISO 17025) requirements to ensure the fairness of the test data.

Process Validation

Our product verification and process validation are in line with ISO 11607.

TFDA

Our medical packaging (sterilization wrap) design and manufacturing processes have passed TFDA GMP certification.

ISO 13485:2016

Our medical packaging (sterilization wrap) design and manufacturing processes passed ISO 13485 certification in 2016.

ISO 13485: Quality Assurance Systems-Medical Devices.

ISO14644-1

Our medical packaging manufacturing environment is validated by 100,000 (Federal Standard 209E)/Class 8 (ISO Regulatory Classification)/C Zone (EU GGMP).

U.S.

21 Code of Federal Regulations (CFR) Part 820 Quality System Regulation (QSR) for Medical Devices and related regulations.

European Union

EU directive 93/42/EEC concerning medical devices.