Quality System & Regulatory Requirements

  • ISL conducts all services in accordance with a quality system that complies with 21 CFR Part 820 and is registered through TUV to the ISO 13485:2016, EN ISO 11135:2014 Quality Standard, providing full scale FDA and ISO compliance.
  • ISL is an accredited medical device sterilizer under JPAL.

View our Certification Documents:

ISO 13485 2016