Clinical Device Group

A quality management system providing a prototype mission statement, job descriptions, and editable procedures for biological safety of medical devices.

Animal biological safety tests, preclinical safety reviews, and biocompatibility assessments by experienced toxicologists.

A comprehensive collection of statements, policies, procedures, templates, and supporting documents containing everything needed to set up a clinical research function.

Workshop covering clinical research quality management systems.

Project management services for clinical research, including Gantt chart creation, long-distance communication management, investigative site budget research and negotiation, investigator invoicing, and earned value calculation.

Workshop covering project management for clinical trials.

Preparation of essential clinical evaluation reports, investigator's brochures, and medical writing for regulatory submissions.

Workshop covering how to write clinical evaluations.

Comprehensive clinical trial management and CRO services including protocol development, investigator site recruitment, and trial monitoring.

Pre-IDE meetings, regulatory strategy, 510(k) and PMA submissions, and quality management system compliance assistance.

Three-ring bound, illustrated guide applying clinical research methodology to medical device evaluations.

Workshop on 21 CFR Part 812 under development.

A book describing the basics of biological safety testing and recommending a strategy for managing biological safety testing for medical devices.

An introductory book on the fundamentals of medical device regulations, covering historical approaches and international frameworks.

Workshop covering ISO 14155 standards for clinical investigation of medical devices.

The field guide for monitoring medical device clinical investigations, containing full text copies of US regulations, excerpts and checklists of ISO 14155 requirements, tables, charts, and resources.

A 4.5 hour presentation consistent with both US and EU regulations that provides detailed guidance on clinical protocol design, accompanied by a fill-in-the-blank protocol template.

A ten-page notepad and mousepad that acts as a tool for identifying biocompatibility tests recommended by ISO 10093-1 and US G95-1.

Workshop covering regulatory permissions.

Workshop on crafting a 510(k) submission, currently under development.

Introductory workshop designed for people new to medical devices to learn the basics of FDA device regulations and how to determine if a clinical study is needed.

A comprehensive 'how-to' book setting forth the requirements, responsibilities, and authority of clinical trial monitors consistent with FDA regulations, guidances, and ISO 14155 standards.

Consulting services to review existing protocols, write new protocols, or advise on study-related matters on a retainer basis.

Workshop covering the European Union government structure, Parliament, Council, Commission, and medical device review and approval systems.

A book providing strategies for writing protocols, making design choices, manipulating sample sizes, and offering example sponsor documentation tools for medical device clinical trials.

Workshop covering Investigational Device Exemptions (IDEs).

Workshop covering IRBs, ethics committees, and privacy laws.

Workshop covering clinical protocol and trial design.

Workshop covering case report forms and data management, under development.

Professional medical device clinical research services for database design and entry, utilizing a stepwise procedure to build databases, define field specifications, write code, verify fields and reports, and perform data entry.

Workshop covering registry studies for medical devices.

Workshop covering adverse events and effects in clinical trials.

A waterproof plastic paper wheel designed for quick, preliminary classification of adverse events and effects in the clinic room or meeting room, complying with ISO 14155 and CFR Part 812.

Workshop covering study budgets, cost tracking, and cost analysis.

An e-conference covering Canadian Medical Devices Regulations, Investigational Testing Authorization provisions, common pitfalls, and privacy legislation.

A training session discussing the subtleties of investigator responsibilities, sponsor compliance, and a comparison between FDA guidance and the ISO/DIS 14155 standard.

Workshop covering protocol deviations and amendments.

Workshop covering global consensus on good monitoring practices.

Heavy writing paper designed for mouse control and note-taking during clinical investigation team meetings, featuring definitions of subject-reported or investigator-observed occurrences.

A two-hour pre-recorded presentation and training session on the FDA draft guidance for industry regarding risk-based monitoring approaches for clinical investigations.

Pre-inked red ink stamp with a 5/8 inch by 1 3/4 inch footprint used for marking case report form copies in clinical studies.

An e-conference teaching how to apply risk management concepts to the clinical research process to make objective decisions about clinical studies.

An e-conference detailing data management activities from case report forms intake to database delivery to the statistician.