Medical Devices and In Vitro Diagnostic (Medical) Devices (IVDs)
Our services include, but are not limited to, the following areas in medical devices including IVDs.
- Global Medical Device and IVD Regulatory Assistance
- Regulatory Documentation, Preparation, Submission, and Approval/Clearance/Registration (e.g., FDA 510(k)s, PMAs, Pre-IDE, IDE, HDE, and CE Marking) in US and Outside US (OUS)
- To read about 510(k) contents, go here >>
- Postmarket Requirements
- Compliance Activities
- Risk Management
- Identifying and Interpreting Guidance Documents (Medical Devices, IVDs, and Radiation-Emitting Products)
- Identifying and Interpreting Standards (Medical Devices)
- Identify and Interpret Data Standards (Medical Devices)
- Device Registration and Listings
- Medical Device Reporting
- Importing and Exporting Devices
- International Regulatory Information (Medical Devices)
- Unique Device Identification
- Quality Management Systems (ISO 13485 and 21 CFR Part 820)
To get familiar with medical device software: regulatory and quality requirements
- Go here to view a list of representative documents useful for consideration for regulatory and quality purposes.
To learn about various devices
- Click here to learn about Trauma Care devices.
- Click here to read about Hair Removal devices.
- Click here to read about Intraocular Lens.
- Other medical devices that may be of interest to consumers. Go here >>
To learn about patient safety information
- As for the Intense Pulsed Light Therapy devices, go here >>
FDA Device Approval Information
- FDA approves new silicone breast implant
- No Longer in the Dark: FDA approves the Argus II Retinal Prothesis System
- Recently-Approved Devices
- 510(k) Clearances
- PMA Approvals