Black & Black Surgical is certified to and maintains a quality management system in compliance with ISO 13485:2016, MDSAP, and MDD 93/42/EEC to ensure that each product sold meets the highest level of quality.
We have applied for MDR certification and continue to sell products into the European Market through the extension provided by Regulation (EU) 2023/607.
Please contact us for a list of items that can be sold into the European Market.
