Medical Device Development and Risk Management

Clinical Studies

Outcomes and "me too" based clinical studies

Complete clinical research management

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.

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Quality 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


510(k) Decision Tree
Deciding 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