Clinical Studies
Outcomes and "me too" based clinical studies
Complete clinical research management
- Develop investigational protocols
- Develop informed consent forms
- Develop case report forms
- Obtain IRB approval
- Luminary site setup, education and clinical study roll-out
- Investigational protocol change management
- Audits and monitoring
- Recordkeeping audits
- Annual reviews
- Clinical study closure
Data integrity management
Web-based data capture and data binning
Download Sample CRF
Track record...
Over 100 devices documented in clinical investigational protocols and IRB-approved.
View Case StudyQuality Systems
Quality: Now™
A true quality-system-in-a-box™...
Comprehensive set of SOPs, Forms and Guides
(guidance documents)
Intended exclusively for small and start-up medical device manufacturers
Empowers manufacturers to rapidly deploy, implement and maintain a compliant, robust quality system
Downloads
510(k) Decision TreeDeciding Whether to Submit a 510(k)
FDA quality system regulations (QSR)
Compliant with both FDA quality system regulations and ISO voluntary regulations
Implements ISO 14971 standard for risk management
Service contract provides for quarterly audits of various aspects of the quality system to document and assure compliance
Track record...
- Currently undergoing beta-testing and evaluation
- Design Controls, Document Controls and Configuration Management modules reviewed and APPROVED by FDA Office of Compliance
US, EU, CAN Registrations
FDA submissions and reports
- Diagnostic imaging devices and accessories (e.g., MRI and ultrasound)
- Lasers
- PACS (Picture Archiving and Communications Systems)
- Interventional radiology
- Steam sterilizers
- Bone densitometry
- Minimally-invasive surgical devices
- Infrared digital thermometers (OTC)
- Initial reports for laser products
Registration Clients and Track Record
Deciding Whether to Submit a 510(k)
FDA quality system regulations (QSR)
Case Study
MRI-Compatible Accessory
COASTAL recently participated in end-stage product development for an MRI-compatible accessory, and performing comprehensive product management activities.
Coastal Consulting's Role
- MRI safety testing at 1.5T and 3.0T
- MRI compatibility testing at 3.0T
- Develop on-device labeling
- Risk assessment compliant with ISO 14971
- Develop product specifications
- Develop materials analysis report
- Revisions to product brochures
- RSNA'03 Hot Topics presentation
- Pre-clinical testing presentation to Harvard Medical School
- Develop white paper describing testing and results in support of marketing
- Develop manuscript detailing testing and results submitted to journals
- Develop and submit 510(k) premarket notification to FDA
- P.O. Box 1294
- Moon Township
- PA 15108
- T: 724 713.2298
- contact@coastalcg.com