Product Development
STAGE 3 – INNOVATION & ENGINEERING SERVICES
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Testimonials
Juan Carlos Lopez-Tonnazi
Chief Engineer, FreeFall Aerospace
"The Altaviz team was very responsive and technically strong. They quickly understood our issues and developed a manifold and cylinder system to inflate our unique Satellite communications antenna that met our stringent technical, performance and weight requirements”
Apellis
“We value your partnership and are excited at the opportunity to work with your organization to bring access and convenience of the injection kit to market, alongside SYFOVRE. We look forward to the continued joint success of our companies and express our sincerest appreciation for your support and dedication on this exciting journey.”
TO & COO pharma customer
“The growth for Altaviz is great! You have made quite an impact in the auto injector industry. Everyone I talk with seems to be quite familiar with Altaviz. I believe it is the only way to make a highly reliable and cost-effective AI.”
Customer President
“The Altaviz Implant Delivery System is the Best in Class in the World!”
Customer CEO
“The Altaviz Gas Injectors are true innovations that solve a problem. Get it to customers & patients asap. It’s a win-win!”
Service descriptions
Human Factors
Human Factors, also known as Usability Testing is a formally controlled assessment of how a design will be used clinically by the end user/patient. The purpose is to either (1) demonstrate user preferences of certain design elements (formative) or (2) demonstrate that a finished product is able to be used as intended without patterns of preventable use errors or difficulties that could result in serious harm to the user or patient (summative).
Risk Management
Every development project requires a fine tooth comb no matter how small. Under our Risk Management program, we perform systematic identification of potential product risks and the associated patient harms. When finished we take this report and make the appropriate design mitigations to reduce risks to acceptable levels. In most cases, ‘acceptable levels’ describes the likelihood of an event whose probability of occurrence is small and whose consequences are so slight.
DFM
Design for Manufacturing (DFM) is the process of designing parts, components or products for ease of manufacturing with an end goal of making a better product at a lower cost. With this step, it is our goal to make the manufacturing process as simple, efficient and cost effective as possible, without infringing on any of the the product’s main directives.
Sterilization
Sterilization is the process of eliminating all forms of microbial life on a product through physical or chemical methods. The identification of the most efficient and cost effective sterilization technology for the product is often a differentiating factor for a products development cycle. We also maintain the ability to perform sterilization validations for specific products as well.
Packaging
The rest of the development lifecycle goes out the window if your packaging isn’t up to par. At Altaviz we are experts in designing the appropriate product packaging complete with package integrity testing, compatible with sterilization methods, and cost controls to ensure the product arrives intact and operatable to the highest standards.
Verification and Validation
Verification and Validation (V&V) testing consists of a variety of activities dependent on the product: biocompatibility, shelf-life/stability, accelerated/real-time aging, bench top performance, analytical chemistry, and more. It is paramount to establish assurance that a product or system looks, behaves and operates to highest standards of expectation.
DHF and Tech File
The Design History File (DHF) is primarily an organizational tool meant to show that the design controls process was properly followed and documented throughout product development. The DHF falls under FDA guidelines, while its counterpart the Technical File falls under EU guidelines.
Quality Plan
The Quality Plan defines objectives, steps, responsibilities, deliverables and dates, quality requirements and assessment methods. In addition it also outlines pertinent regulatory requirements such as responsible individual or organization required to complete a project.