Medical Device Consulting Regulatory Quality Complaince

The Case for Outsourcing

So Much in Common - So Outsource

The case has to be made for doing the same thing with elements of risk assessment relating to medical devices. We can provide source documents that integrate into your Design History File.

We are efficient for you for the same reasons that testing houses can be efficient: they use common test methods to test device from competing companies.  They share economies of scale to reduce the overall costs to their customers of obtaining such testing results and use with confidentiality agreements to ensure the protection of intellectual property. In the same way, Ironbarque can navigate the CER process for you more efficiently by maintaining the common elements for devices of a similar type.  We too work under confidentiality.  

We share across customers the costs of maintaining a watching brief on classes of devices and groups therapies.

For example, all central vascular system devices share a large set of harms in common and have implant approaches for which the risks are fairly constant and well understood.  Many companies cannot afford to have full time staff with medical training on staff and if they can, they may often choose to outsource the "grunt work" behind CER.

We work under standard operating procedures with documented and thorough literature searches and analyses. Physician input is given with the hazards analysis and literature review / CER generation. Statisticians are involved in training our own staff in the assessment of the statistical strength of data using methods modeled on those documented by the Cochrane Group, the review process of the AHA/ACC Committees and the Center for Evicence Based Medicine.  We involve engineers with appropriate training to ensure that we graft well onto your internal FMECA process.

We work with medical libraries to ensure that we obtain full articles. Such common data (such a journal articles) are stored and are available as proof sources to our customers for individual study or submission. We do not breach copyright and will not provide mass copies of any article.

We welcome your audit of our internal processes.