What is MDDS
Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in
combination that display unaltered medical device data, or transfer, store or convert medical device data
for future use, in accordance with a preset specification - ยง 880.6310 Medical device data system.
MDDS manufacturers must comply with FDA 21 CFR Part 820 (Quality System (QS) Regulation/Medical Device Good
Manufacturing Practices), register annually with the FDA as device manufacturers and provide listing information
for your MDDS products.
The rule covers healthcare industries that include:
- Medical device manufacturers.
- Information technology companies that design, install or market these systems.
- Blood Banks, Hospitals and Laboratories that develop them in their facilities.
Important Dates:
- May 18, 2011: Manufacturers are required to Register and List with the FDA.
- April 18, 2012: Manufacturers are required to implement a compliant Quality System and begin
reporting adverse events.
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What is eMDDS:
- eMDDS is a web based, anytime, anywhere application that will help you decide whether the hardware or
software you plan to deploy in your blood bank, hospitals, lab or other healthcare facility is an MDDS or a
BECS or not a medical device. The decision is made based on the answers you provided.
- eMDDS has a background algorithm built-in that will match your answers to the FDA regulations and form
an opinion as to the kind of medical device you have. Based on the answers you provided, the application will
issue you a certificate as shown. It has an option to allow you to upload your user requirements to Calimex for
software development, if you so choose.
- eMDDS is fast, simple, paperless and very affordable application.
Benefits:
- Anyone in your company can determine whether your device is a Medical Device Data System.
- You save time and money on our self-service, automated process - time and money saved in meetings,
on consultants, acquiring regulatory knowledge and in other delays.
- Calimex issues a device certificate that you can hold as evidence of your due diligence.
Calimex stands behind its certificate.
- You can run the self-service from anywhere, generate the certificate and email them to the quality or
regulatory department.
- You can initiate your computer change control process immediately on obtaining the certificate.
- Remember, Calimex can do the whole process of documentation, writing the code and registering with FDA
thereby shortening your software development life cycle (SDLC).
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