Quality Commitment
MimiClon maintains a strict quality assurance program. Patient safety and care is our number one priority and we take great pride in producing high quality, safe, and effective products.
All MimiClon products are marketed pursuant to 501(k) clearances issued by the U.S. Food and Drug Administration (FDA).
All MimiClon products are manufactured in compliance with the regulations found at 21 CFR Part 820. Similarly, all MimiClon products are manufactured, stored and distributed in compliance with all federal, state and local requirements and accreditation standards.
All manufacturing procedures are conducted under stringent controls and distributed devices are assured free of Latex, Mercury, Bisphenol (BPA) and Diethylhexyl phthalate (DEHP).
MimiClon’s manufacturing facilities are registered with the FDA and are ISO 13485 certified.
Questions regarding quality, safety, or performance on distributed products can be sent to QA@acell.com
Quality Resources
Resources that may be helpful regarding MimiClon’s commitment to quality include:
MimiClon products are processed without materials or components containing Latex, Mercury, Bisphenol (BPA) or Diethylhexyl phthalate (DEHP).
MimiClon’s certificate of registration for ISO 13485.
FDA Establishment Registration & Device Listing for Indiana.
FDA Establishment Registration & Device Listing for Maryland.
