BioPro has been registered by Intertek as conforming to the requirements of: ISO 13485:2016
BioPro has been registered by Intertek, an MDSAP recognized auditing organization, as conforming to the requirements of: ISO 13485:2016 for
- Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6)
- Canada: Medical Devices Regulations – Part 1- SOR 98/282
- United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)
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