Why Choose Intertech: The Intertech Difference
Quality of Work
- Medical Device Experts - Designing medical devices is very different from designing consumer devices because it involves designing for safety and effectiveness in devices in an environment that requires compliance to a large set of overlapping regulations, standards and guidance documents. Intertech Engineering Associates, Inc. has been in business developing medical device software since 1982, and medical devices are all we do. We have very experienced medical device engineers that understand the design challenges across multiple engineering disciplines in a regulated environment.
- The Intertech Quality System - Intertech has its own internally developed processes, procedures and tool sets that can be utilized when a client’s process does not exist. Our processes also allow immediate initiation when an urgent need arises with our clients.
- Medical device process leadership - Intertech’s experience is proven as its team members participate in industry committees and workgroups, often with FDA participation. Specifically, our employees have contributed to the 62304 Software Lifecycle Process Standard, TIR32 on Medical Device Software Risk Management, and TIR36 on Automated Process Software Validation. Intertech is recognized across the industry by its longevity, project successes, and through trade press publications, presentations, AAMI courses, frequent webinars and MD&M workshops. Our corporate experience has been encapsulated in the published textbook Medical Device Software: Verification, Validation, and Compliance. We are represented on the MD&DI magazine editorial advisory board, and our company president was honored with a “100 Notable People in the Medical Device Industry” award from MD&DI magazine.
Communications and Transparency
- Partnership commitment – Intertech seeks to partner and participate with your current resource teams to address short term and long term engineering needs as new opportunities and new challenges occur. Long term relationships are the most efficient, and cost effective relationships we have with clients.
- Transparency – In addition to the project management status reports and meetings, we provide clients with direct access to Intertech’s tools. All artifacts created are then provided at the end of the project to support any archive requirements necessary. In short, you as the client see what we see as the project progresses.
Meeting Deadlines and Milestones
- Project Management - Each project is coordinated with a designated Project Manager who develops estimates often based on historical experience, plans schedules and monitors spending on a weekly basis. Weekly status meetings keep the project team focused on reporting progress, planning upcoming activities, and predicting future issues while there is still time to manage around them.
- Managing to schedule and budget – Intertech will prepare and update a schedule and reconcile the ongoing budgets on a weekly basis.
Experienced resources on staff – Intertech is not an engineering recruiting firm, aka a supplemental resource agency, or independent consultant placement agency. Those agencies typically only address short term needs with temporary independent consultant engineers. Intertech builds, maintains and leverages experienced teams to the benefit of our clients. Our business model of using full time employees as engineers provides the maximum engineering continuity to our clients. This results in increased efficiencies and avoids most engineering re-work efforts.
Outsourcing engineering to other supplemental resource agencies can be costly when inexperienced staff is used, or a promise that more engineers at a lower rate is the answer. It is not. Intertech has frequently been brought in to clean up after such situations.
Longevity and Stability
- Corporate longevity – Intertech has been in business since 1982 and has a successful history in retaining high skilled resources, committed and dedicated to long careers with Intertech and its clients. Many times our experience on projects outlasts the client’s technical resources. Building a partnership with us will provide an alternative technical resource; experienced in technologies important to your business.
- Practical medical device approaches - Intertech’s design skills start with an understanding that design solutions embody themselves in the Intertech approach. This approach includes fitting the appropriate architecture, implementing with defensive programming considerations, applying appropriate and immediate review and analysis against expectations and safety risks. Intertech’s processes rely on assurance that well established requirements directly correlate to effectiveness in verification as well as applying verification earlier in the process improve effectiveness and assure a sense of urgency to meet client quality and timeline needs.