Medical device CROs

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By: Chanderkanth -- Senior Research Analyst

28 March, 2013

Medical device CROs
WHITEPAPER

Currently medical device CRO market is estimated to be USD 3.2 billion and the market is growing at a healthy CAGR of 12~13%. But, on the account of growing number of recalls and the device OEMs there is a desperate need to route these products into the market at faster pace. Further FDA?s increasing pressure on device makers to adapt PMA process for device approval will boost the Medical device CRO growth in nearing future. Currently 5% of CROs operations comes from devices, however this market is growing at a health CAGR of 12~13%. While European device approval requires OEMs to comply with one of the directives, MDD, IVDD and AIMDD. All the devices which comply with these standards are given CE mark. CROs demand from European region is likely to increase because the regulatory bodies mandate clinical trials for every class of devices unlike US which limits its trial to class III devices owing to the risk associated with them. In case of US, device enters the market either via 510K process or through PMA. 510 k process is applied to class II devices and expects device to have equivalence in regards to efficacy and safety in par with predicate device.PMA is for class III devices since they are of higher risk to patients on the account of their invasive nature.




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