Intertech - Medical Device Development

Intertech Engineering Associates is a leader in medical device design, development, verification, validation, consulting and training. Intertech is a Massachusetts-based corporation that has been providing a variety of services to the medical device industry since 1982. We help clients to design, develop and validate their products, manage their projects, and build their own internal expertise and training infrastructure.

MEDICAL DEVICE DESIGN

Our 25-year focus on the medical device industry has made Intertech’s experienced engineers keenly aware of the regulatory challenges its clients face with new product design and development. This has enabled the company to apply its software and electronics engineering experience in ways that helps clients navigate their projects through the regulatory stages.

Intertech’s design control policies and procedures are traceable to regulations and guidelines from the FDA. Our expertise in software validation is widely recognized within the industry. The company is a leader in helping manufacturers with the validation of quality and production system software (21CFR820.70i).

MEDICAL DEVICE SOFTWARE AND ELECTRONICS

Intertech’s technical expertise is centered on medical device software and the electronics that support it. Additionally, Intertech is skilled in software and product validation, regulatory compliance, and the management of requirements, projects and product risk.

MEDICAL DEVICE SOFTWARE TRAINING

Customised on and off-site training is available, which can run from 1hr seminars to multi-day workshops. Intertech currently has training programs on Developing Compliant Medical Device Software, Validation of Medical Device Software, Dealing with GUI Requirements, Software Risk Management, and Validation of Production and Quality System Software. Intertech has also collaborated with AAMI to present the AAMI software validation class.

MEDICAL DEVICE DEVELOPMENT ADVICE

The depth of Intertech’s involvement is tailored to the demands of a client’s situation. Intertech advises and trains clients seeking to broaden their knowledge base, or will lead by example and work with clients to advance their schedules and reduce project risk. Projects range from supplementing the client’s staffing in a specific discipline to full turn-key design, development and validation.

Intertech offers four levels of services: evaluations and assessments, training, consulting and coaching, and hands-on engineering.

MEDICAL DEVICE ASSESSMENTS

Intertech provides this level of services to clients who want in-depth project status assessment and detailed recommendations for services needed. At this level, Intertech may conduct a demonstrative ‘friendly audit’ or assist in technical or regulatory due diligence on acquisitions or investments.

Intertech prides itself on leading the client’s staff by example and actively contributing to projects. This approach supplements consultative advice on how to best address problems and deficiencies. Intertech’s hands-on services include reviews, project management, requirements development, traceability analysis, software development and implementation, and electronics design and development.

DEVICE VALIDATION CONSULTING

Intertech forms consultative relationships with clients working through their first device development project. Additionally, the company assists those attempting to create or streamline SOPs for device development and validation.

This level of service may benefit clients who have employees not from the regulated medical device industry who are experiencing difficulty adapting to the regulated environment. Intertech will help avoid regulatory compliance problems by developing an engineering process, periodically reviewing progress, or acting as an on-call expert resource.

Our projects have spanned a range of biomedical fields including audiology, cardiology, dialysis, medication delivery and 3D imaging. Clients include Fortune 500 medical device manufacturers and large international companies. Intertech also works with small companies and has successfully contributed to launching several venture-funded startups.

Intertech has been a regular contributor to industry workgroups and standards committees on software risk management and validation. Intertech employees are actively conducting workshops at national and international tradeshows, to supplement corporate training offerings. Intertech’s expertise in risk management, product development, validation, and project management is shared in numerous trade publications. Intertech contributes to the editorial advisory boards of three industry publications.