Medical Device Regulation
Claigan has extensive experience in restricted materials compliance for global medical device regulation including the new EU Medical Device Regulation (2017/745). Typical evaluations can involve a range of specific restricted substances such as DEHP, BPA, latex, and nano materials; or the wider range of carcinogens, mutagens, reproductive toxicants (CMRs), and sensitizers.
Typical medical device regulations
- EU Medical Device Directive
- EU Medical Device Regulation
- US FDA latex warnings
- Health Canada device licensing
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