Medical Device Consulting Regulatory Quality Complaince

Not a Charity but a Business

Even the United States is now recognizing International Standards; these standards drive to a common set of tests being conducted as part of product development. Governments have a common understanding to what to expect in a submission. Companies are increasingly moving to external, independent, testing houses to conduct device validation testing. The testing laboratories have expertise and an independence in reporting the result that encourages faith in the results.

CER need to be both established and then maintained. The requirement for Post Market Surveillance in the EU is being matched by an increasing enforcement by the FDA in term of maintaining the Design History Files of 510k devices ( DHF have always had to be "maintained" but enforcement on 510k devices is increasing - PMA DHF were already more heavily reviewed).

The case now 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 housing can be efficient: they use common test methods to test device from competing companies with confidentiality agreements ensuring 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.