Great Software Through Quality Assurance

Some New Harbor success stories

Provided software quality oversight for a widely distributed product development team delivering the control system for a cardiac implantable therapeutic device. Drove requirements analysis and documentation through multiple peer reviews. Conducted a project quality gap analysis which led to a re-designed software quality strategy and a comprehensive V&V protocol. Executed software FMEA and devised an end to end traceability matrix. Evaluated software project documentation against relevant regulatory requirements and international standards Hired by a contract R&D firm to rescue a troubled project for the validation of a Thermal Ablation medical device to be used in the operative suite. Initiated bottoms up requirements review, completely redesigned and rewrote the validation protocol, devised fault insertion protocol strategy and developed validation traceability matrix. Collaborated with another CSV firm to support the ISO 13485 re-certification of multiple software applications at a medical Implantable Textile manufacturer. Reviewed and rewrote application requirements and validation protocols. Included rapid acquisition of knowledge of all relevant SOPs. Conducted an end to end gap analysis of the test and validation process to resolve a severe quality problem with device Embedded software. Drove multiple specific corrective actions including adding formal regression testing, closed loop feedback from the CAPA system and risk analysis for maintenance releases. Developed a Corporate Quality System Audit strategy and implementation plan based on ISO 13485 for a company that provides enterprise level Trials Management software to leading Clinical Research Organizations. Includes a review of all internal quality policies and SOPs against standards and regulations relevant to the QSR, GMP and Electronic Records requirements. Developed and executed the Verification and Validation test protocol for a next generation Cardiac Catheterization lab system. Included technical support of multiple clinical trials and follow-up redesign and subsequent validation efforts.

What Sets Us Apart

Proven experience in creating great, high-quality medical software. We know how to get the job done! Decades of results through quality assurance and testing in a regulated environment. Quality and Process is our way of life! Our approach allows your team to deliver a product that fulfills its intended use while staying on time and on budget. You're not just a customer, but a partner!

New Harbor SQA, LLC 855 Turnpike St 978-965-21111 www.newharborsqa.com

Professional Expertise to make you successful:

Design Controls and Quality Systems
21 CFR 820, 21CFR Part 11, IEC 62304:2006, ISO 13485:2003, IEC 60601: 2005

Software Risk Management

ISO 14971:2007, IEC 60812:2006, AAMI TIR32:2004 Risk Strategy and Planning Hazard Analysis and Mitigation FMEA/FMECA

Audits and Gap Assessments Peer Reviews and Code Inspections Supplier Selection and Process Validation Development Process Assessment Requirements Gathering, Analysis and Verification Documentation and Traceability Implementation Defect Management and Change Control Configuration and Release Management

Software Quality Assurance Planning and Strategy Development

Standards and Regulatory Compliance Quality and Development Plans Verification & Validation Planning Metrics and Reporting Development Project Estimation, Execution, and Reporting

Outsourced Engineering
New Product Software Development for Medical Deviceson time, on budget and done right. Verification & Validation Testing Serviceassurance that your software is safe, meets requirements and is compliant. Sustaining Engineeringoptimize revenue, maintain customer loyalty, free up your developers. Computer System Validationkeep your process compliance updated.

In-House Training
Fundamentals of Software Quality Assurance Software Development in an FDA-Regulated Environment Custom Course Development to Meet your Unique Needs

Are you feeling the pressure?

Development seems to go on forever and no one knows why? Is end to end traceability your worst nightmare? Are the product requirements a moving target? Does your documentation keep pace with the product? How good do you feel about your software risk assessment? Is your software lifecycle a disjoint set of tasks? Outsourcing straining the management team? Support and maintenance costs squeezing profits? Your field support organization is overwhelmed with product complaints? Technical team overloaded with projects?

New Harbor SQA works with you to solve these problems and others. In short, we will help you build better software in less time and at a lower cost! We have a passion for delivering great product driven by a belief that making our clients successful is the key to long term business success of all the stakeholders. We apply a software industry Best Practices approach within a Standards and Regulatory framework in helping you create an end-to-end process that works and is compliant. We bring all our skills and experience to bear on your problem with a flexible engagement model and a nononsense hands-on approach that adds value every step of the way.

A proven process that is driven by International Standards and Best Practices.

Quality Management System (ISO 13485) Risk Management Process (ISO 14971)

Software Development Lifecycle framework of processes, methods and activities (IEC 62304) SOPs (IEEE Standards for Software Development)

Industry Affiliations

Software Quality Consulting, Management and Outsourced Services for Medical Software Working with companies or all sizes to improve their results. Tony Raymond, President
978-965-2111 tonyraymond@newharborsqa.com www.newharborsqa.com 855 Turnpike Street, North Andover, MA 01845