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REGhelps help organizations to overcome regulatory hurdles by sharing, guiding, training and developing documents that of high quality, economically viable and assurance of clearance .
As knowledge driven team that aims to be strategic outsourced partners to customers, we strive to build a good long lasting tie up with every customers who provide business to us. Continue to be curious and constantly educate our self in new ways of solving new regulatory requirements .
One step ahead. All the time.
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CE mark stands for Conformité Européenne and this is a legal requirement to place the medical device on the market in Europe. CE mark shows conformity with the European Union Harmonization Legislation and EU Medical Device Regulation.
In order to be CE marked or CE labelled, firstly, medical device should comply with the ‘general safety and performance requirements’ laid out in Annex I of MDR or IVDR. Secondly, medical device must undergo conformity assessment procedure based on its classification and risk.
REGhelps team of consultants provide complete support for new Medical CE Marking or migration from MDD/IVD to MDR/IVDR