We've posted some links to various web sites that you might find helpful. If you know of any sites that may be of general interest, please let us know and we will try to incorporate them here.
If you go to a listed link, you may return to this page by clicking on the BACK arrow located on the top left of the browser you are using.
Subject - Click on Highlighted Text to go to Link |
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| Medical Device Forum | The Medical Device Forum is a place for Medical Device industry professionals to share ideas, discuss current issues, or seek solutions regarding the design, manufacture, or regulation of medical devices. |
| MDSS | Provides an Authorized European Address for companies needing an AEA for CE purposes. MDSS provides an address and complaint adverse reporting responsibilities. |
| European Authorized Representative & CE Marking Consultants | Obelis European Authorized Representative Center (O.E.A.R.C.) provides CE Marking regulatory compliance consulting to manufacturers worldwide, in accordance with European Directives such as MDD 93/42/EEC, IVD 98/89/EC , and Low Voltage Devices 73/23/EEC . Our high quality compliance solutions, proven by our ISO 9002 certification, include Commercial, Regulatory, Administrative, and Market Development Services through our Brussels, Belgium headquarters. Our worldwide regulatory solutions are provided through our global and professional One Link One Solution Network. We will help you get to the next level |
| FDA Home Page. | FDA provides an array of key information including |
| Code of Federal Regulations | Search the entire CFR by section |
| Federal Register | Search the FR for key device developments. |
| FDA DSMA | Site contains useful information for the small device manufacturer. |
| RAPS | Regulatory Affairs Professional Society |
| PDA | Parenteral Drug Association |
| (FDLI) | Food & Drug Law Institute |
| (ANSI) | Amer. National Standards |
| (BSI) | British Standards |
| (DIN) | Deutsches Institut fr Normung e.V. |
| (TOC) | FDA DMSA Table of Contents |
| 510(k)s | Information on Releasable |
| (ISO) | ISO Online |
