Your Partner for Regulatory Success
Expert regulatory affairs consulting services tailored to help businesses thrive in today's competitive medical device landscape.
Services at a Glance
Regulatory Strategy Development
Building a regulatory strategy to meet the needs of both the device and your business.
Submission Preparation and Support
Preparing and submitting regulatory submissions specific to your device.
Interfacing with Regulatory Bodies
Supporting your business by ensuring regulatory body communication goes smoothly.
Detailed Experience
SUBMISSIONS
- US 510(k) and 510(k) with clinical data
- Humanitarian Device Exemption (HDE)
- Investigational Device Exemption (IDE)
- Q-Submissions
- 513(g) request for classification
- US HDE, IDE, and laser product annual reports
- Post Approval Study (PAS) Progress Reports
- EU MDR Class IIa, IIb TechDoc Creation
DEVICE TYPES
- SaMD including AI/ML algorithms
- Software used in medical device design
- OTS Software and SOUP
- Orthopedic devices
- Patient Specific devices
- US Custom devices
- Anesthesia breathing circuit equipment
- Oxygen, capnography, and N95 masks
SERVICES
- Risk Management (ISO 14971)
- Global change assessment
- Engineering and clinical documentation review
- Labeling and advertisement review
- Audits and conformity assessments
- QMS development and certification
- QMS maintenance and document control
- US recall strategy development and notifications