Regulatory Support
As a medical device manufacturer, we have regulatory experts on staff that monitor the ever-changing regulatory environment and assist you with streamlining your approval process on new products. Baxter collaborates with you to provide the necessary regulatory documentation to help ensure the timely delivery of your products to market.
We maintain Drug Master Files for all products sold to pharmaceutical companies and our Product Specifications indicate materials of construction and conformity to applicable biocompatibility requirements. All materials of construction are compliant to food contact requirements, BSE&TSE regulations, European Pharmacopeia and relevant ISO 10993 Biocompatibility requirements. Our products fully comply with all regulatory requirements, including ISO 13485:2003, 21 CFR 820,
MDD 93/42/EEC as amended by 2007/47/EC, WEEE 2002/96/EC and our own Quality System requirements. We manufacture to cGMP standards and follow lean manufacturing principles.
Products are CE-marked, as appropriate.
All appropriate certifications and documentation are available upon request.
