Consulting
Bruce Haggar - Principle Consultant
Over forty years of broad experience and management accomplishments in the Medical Device area including training, medical device engineering and development, manufacturing including process validation, and quality assurance systems. Regular Presenter for various national meetings on medical device quality and regulation, editor of the Biomedical Quality Auditor Handbook, and certifying consultant for FDA-related compliance actions for large and small medical device manufacturers.
About MedQ Systems
MedQ Systems offers the expertise to identify critical operational elements of each biomedical technology business that are essential for aggressive time-to-market performance. Our expert management team can develop and integrate these elements within the unique characteristics of your organization, its products/services, and its overall business strategy.
If a product is commercialized without this basic integrated systems approach, its performance in the marketplace is likely to be substandard and subsequent improvements are costly. Also, the evolution of its technology to improved versions and to other products is usually difficult without reconstructing the areas of weakness or sometimes even starting over.
For example, the MedQ Systems approach can help to achieve these characteristics of success:
- Product design assurance with sound linkage to customer requirements.
- Complete and functional design documentation that assures such capabilities as launch timeliness, outsourcing, design enhancement, and cost reduction.
- Clinical studies that help justify reimbursement.
- Strong strategic supply chain development that avoids component shortages, obsolescence, or complete supply failure.
- Thorough but practical manufacturing process characterization and validation that prevents product performance failures and even field corrective actions.
- Thorough product and process risk assessment that guides resource focus during design and design transfer activities.
- Effective awareness, communications, and coordination with key regulatory agencies that minimizes time to marketing approvals and strengthens compliance position.
Regardless of business size, development stage, or technology, MedQ Systems expertise can add value to your business development efforts. By combining its seasoned management with a network of strategic partners and associates, we guide clients to improve operating performance, reduce time-to-market, and resolve FDA/regulatory compliance issues.
Consulting Services
We advise biomedical technology clients in start-up business development as well as re-engineering of established businesses, quality assurance systems and compliance, regulatory strategies and submissions, clinical trial design and management, and operations development. This also includes regulatory and quality support for companies with FDA or other regulatory compliance difficulties. Auditing, systems development support, and certification are routine but focused, customized activities.
Our management consulting activities are focused in the following areas:
- Clinical and Medical Affairs
- Regulatory Strategies, Submissions, and Compliances
- Product Development
- Operations Development
- Process Validation and Performance Improvement
- Quality Assurance
We also conduct focused problem-solving, improvement assistance, or project management in such technical areas as:
- Product Quality Improvement
- Regulatory submission preparation
- Biocompatibility assessment
- Sterilization and biological QA programs
- Controlled environment and utilities design and validation
- Documentation systems and change controls
- Design verification and validation, including hardware and software
- Product design and development processes
- FDA/ISO quality system audits and compliance
- Supply chain definition and development
- Supplier evaluations and quality system audits
- Manufacturing process development
- Manufacturing process validation
- Manufacturing systems and performance
- Capital equipment service and repair systems