Recently IAMERS was rated in the top ten sites for international due diligence for medical equipment. Actually we were #3. Take a look, the word is getting around.
Here’s the actual copy from the article:
Regulatory Information and Intelligence Tools: Devices
Medical Device Resources for Europe, Asia and Latin America
Due diligence information is critical when preparing your company’s medical or diagnostic devices for international marketing. Large companies rely on international regulatory affairs staff to manage every detail from product registration to labeling.
If you are a small to midsize company, it is most helpful to get an overview of the regulations before working with outside contractors. Global regulatory inconsistencies and misunderstandings may occur with regard to device classification, quality management, documentation and adverse event reporting. There are many good sources of general information in Table 10.
Table 10: List of “Go To” Sites for International Due Diligence
|CDRH Foreign Liaison List||www.fda.gov/…|
|Global Medical Device Nomenclature—Internationally recognized coded descriptors with ISO 15225 standards||www.gmdnagency.com/?id=nom|
|International Association of Medical Equipment Remarketers and Servicers (IAMERS)||www.iamers.org|
|QMED (formerly Medical Device Link) is a prequalified medical device supplier directory and news source.||www.devicelink.com|
|Medical Devices Canada—Canada maintains a good source of international links.||www.medec.org|
|Medical Product Outsourcing||www.mpo-mag.com|
|Office of Health and Consumer Goods—A US government site with Medical Device Foreign Regulations.||www.trade.gov/td/health/regulations.html|
|The Medical Device Register On-Line—This site contains a lot of 510(k) information.||www.mdrweb.com|