About Coastal Consulting Group

Coastal offers FDA regulatory consulting and support services to small and start-up medical device manufactures, both within the domestic US and internationally. Constantly changing FDA legislation, and the evolution of international regulatory and voluntary standards, has placed an ever-increasing burden of compliance upon the small manufacturer.

Capabilities

• Develop clinical investigational protocols, informed consent and case report forms; perform clinical research management (IRB approval, setup, site education, maintenance, monitoring, data integrity, recordkeeping, annual reviews and closure)
• Identify device characterization test protocols and usage recommendations (verification and validation testing, biocompatibility, disinfection/sterilization, etc.)
• Preparation and successful clearance of FDA 510(k) submissions
• Develop corporate SOPs for FDA QSR compliance
• Ombudsman for ITS/UL testing to voluntary and internationally-recognized standards.
• Prepare analysis white papers detailing aspects of FDA regulation.
• Technical and electronic publications - develop, prepare, review and edit Operator's and Technical manuals. First-ever electronic device submission to FDA.
• Database development

Bio

Mr. James Jochen Rogers holds a BS degree in Electrical Engineering and Applied Physics from Case Institute of Technology, Case Western Reserve University (1986). Since 1987, Mr. Rogers has worked in engineering, service and regulatory affairs capacities for large, small and start-up MRI diagnostic imaging manufacturers, and has represented two of these manufacturers to NEMA's MRI and Ultrasound sections. He founded Coastal Consulting Group in 1993, and continues active participation in the development of NEMA measurement standards, FDA regulations, and international voluntary standards. He holds a patent for MRI cardiac gating technology, and has authored several peer-reviewed journal articles.

An Apple Macintosh evangelist since 1985, he credits the influences of David Byrne, Edward Tufte, Peter Gabriel, and Moby, along with Californian and Italian red table wines, though not necessarily in that order.

Software Expertise

• DTP : FrameMaker, Acrobat, InDesign
• Illustration/CAD : Adobe Illustrator, Ashlar Vellum, Strata 3DPro
• Engineering : Matlab
• General Office : Word, Excel, Equation, Powerpoint
• Image Processing : Matlab, Adobe Photoshop, NIH Image, ImageJ
• Database : FilemakerPro, 4D
• Project Management : MSProject
• Web Design : Adobe GoLive, Quicktime VR Authoring Studio
• Beta-testing : For Macintosh: Adobe Acrobat (ver. 4), Adobe FrameMaker (ver. 4, 5)